A Pilot Study to Determine the Efficacy of Fluorescein Visualization of the Uterus in Detecting Endometrial Cancer Invasion
Phase: EARLY_PHASE1
Conditions: Endometrial Cancer
Sponsor: University of Arkansas

 
 
 
 
 
 
 
A Pilot Study to Determine the Efficacy of Fluorescein Visualization of 
the Uterus in Detecting Endometrial Cancer Invasion 
 
 
 
 
 
 
 
 
 
 
 
 
Principal Investigator: Alexander Burnett, MD 
Sub-Investigators: Matthew Quick, MD;  Kristin Zorn, MD; Matthew Jeffreys, MD 
A.P.N.s: Kimberley Spickes; Susan Miller 
Medical Monitor: Sanjay Maraboyina, MD 
 
 
 
 
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IRB #202459 
NCT01979003 
 
 
 
 
 
 
 
 
 
 

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1. Table of Contents 
 
1. Table of Contents ................................................................................................................................ 2 
2. Abbreviations ........................................................................................................................................ 3 
3. Protocol Summary ............................................................................................................................... 4 
4. Study Schema ...................................................................................................................................... 4 
5. Background .......................................................................................................................................... 5 
6. Trial Objectives .................................................................................................................................... 5 
7. Patient Population ............................................................................................................................... 6 
8. Investigational Agent .. ....................................................................................................................... 6 
9. Treatment Plan .................................................................................................................................... 7 
10. Study Calendar .................................................................................................................................. 8 
11. Risks and Toxicities to Be Monitored ............................................................................................. 8 
12. Data Handling and Record Keeping ............................................................................................... 9 
13. Specimen Storage and Disposal ..................................................................................................... 9 
14. Statistical Considerations ................................................................................................................. 9 
15. Ethical and Regulatory Considerations ........................................................................................ 10 
16. Adverse Events ................................................................................................................................ 11 
17. Monitoring ......................................................................................................................................... 11 
18. Bibliography ...................................................................................................................................... 13 
 

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2. ABBREVIATIONS 
 
AE – adverse event  
CCTO – Cancer Clinical Trials Office 
CFR – Code of Federal Regulations 
CRA – clinical research associate 
CRF – case report form 
CTCAE – Common Terminology Criteria for Adverse Events 
FDA – Food and Drug Administration 
GCP – good clinical practice 
IRB – Institutional Review Board 
IV – intravenously 
mg – milligram 
ml - milliliter 
PI – principal investigator 
PRMC – Protocol Review And Monitoring Committee 
RSC – Research Support Center 
SAE – serious adverse event 
UAMS - University of Arkansas for Medical Sciences 
UPIRTSO/UPR – unanticipated problems involving risk to subjects or others 
 
 
 

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3. PROTOCOL SUMMARY 
 
Primary Objective:  To determine if Fluorescein systemic injection during hysterectomy 
procedure can be useful in revealing the depth of endometrial cancer invasion. 
 
Secondary Objectives: To compare depth of invasion as detected with fluorescein to that 
detected by frozen section and final pathology. 
 
Exploratory Objectives: Can systemic fluorescein injection at time of hysterectomy provide an 
inexpensive and rapid determination of endometrial cancer invasion into the myometrium. 
 
Study Population: Women with endometrial cancer who are undergoing hysterectomy. 
 
Inclusion Criteria:    
1.  Known endometrial cancer and scheduled for hysterectomy as part of their treatment. 
2.  No known allergy to fluorescein dye. 
3.  Ability to understand and sign informed consent. 
4.  18 year of age or older 
 
Exclusion Criteria:    
1. Prior hysterectomy. 
2. Known sensitivity to fluorescein dye. 
 
Investigational Product: Fluorescein dye injected systemically 
 
Study Design: Pilot 
4. STUDY SCHEMA 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
100 women with endometrial cancer who are scheduled for a hysterectomy as 
a part of their initial treatment 
Intravenous injection of 1 ampule (5 cc) of fluorescein dye prior to ligation of 
the uterine arteries during hysterectomy 
Uterus sent immediately to surgical pathology for opening, cross-sectioning, 
and exposure with Woods lamp to determine depth of invasion of endometrial 
cancer into the myometrium.  Photograph taken of representative area and 
frozen section performed at same area 
Comparison of final pathology depth of invasion with frozen section depth of 
invasion and fluorescein dye detected depth of invasion to determine accuracy 
of procedure. 

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5. BACKGROUND 
 
Endometrial cancer is a surgically staged disease. Staging involves removal of the            
uterus, tubes and ovaries as well as lymph nodes in the pelvic and aortic regions. In 
women with cancer that does not invade the uterine muscle or is of low grade and 
invades less than 50% of the muscle, removal of the lymph nodes is not mandatory. 
Intraoperative evaluation of the depth of invasion of the cancer is critical, therefore, in 
determining which patients require lymphadenectomy. Gross visualization is highly 
inaccurate. It is more sensitive to obtain a pathological frozen section on the uterus to 
accurately diagnose depth of invasion. However, frozen section increases the 
operative time and incurs an additional expense for the procedure. A rapid and 
accurate intraoperative assessment of invasion which could be performed in the 
operating room would reduce the time and expense of a frozen section. We propose to 
utilize fluorescein dye given intravenously prior to the hysterectomy to aid in visually 
determining the depth of invasion. If this assessment correlates well with the pathologic 
depth of invasion, then this could represent a valuable intraoperative tool to determine 
which patients require lymphadenectomy. 
 
Fluorescein is approved by the FDA for angiography of the retinal vessels. There are 
many procedures that utilize fluorescein beyond its FDA indication. It is commonly 
used during surgery to assess the vascular viability of tissue, most particularly the 
viability of the intestines when there is concern. In this situation, fluorescein is injected 
intravenously and the intestines are examined using a Woods lamp to detect the areas 
of fluorescence. Areas of poor vascularity will not fluoresce. It is also commonly used 
to detect the boundaries of skin lesions. For example, in assessment of vulvar Paget's 
disease fluorescein injection and visualization of the vulva with Woods lamp can detect 
the extent of the lesion that would otherwise not be detectable by the naked eye. 
 
6. TRIAL OBJECTIVES 
 
a. Primary Objective: To determine if Fluorescein systemic injection during hysterectomy 
procedure can be useful in revealing the depth of endometrial cancer invasion 
 
b.  Secondary Objectives: To compare depth of invasion as detected with fluorescein to that 
detected by frozen section and final pathology 
 
c.   Exploratory Objectives: Can systemic fluorescein injection at time of hysterectomy provide 
an inexpensive and rapid determination of endometrial cancer invasion into the myometrium 
 
 

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7. PATIENT POPULATION 
 
Women with documented endometrial cancer who are scheduled for a hysterectomy as part of 
their initial cancer staging. 
 
Eligibility Criteria:  Subjects are eligible for the study if the following inclusion and exclusion 
criteria are met: 
 
Inclusion Criteria:    
1.  Documented endometrial cancer and scheduled for hysterectomy as part of their treatment. 
2.  No known allergy to fluorescein dye 
3.  Ability to understand and sign informed consent 
4.  18 year of age or older 
 
Exclusion Criteria:    
1.  Prior hysterectomy 
2.  Known sensitivity to fluorescein dye 
 
8. INVESTIGATIONAL AGENT  –  Fluorecein dye for intravenous injection 
 
a. 
General Description: Fluorescein is a synthetic organic compound with a dark orange color 
that is dissolved in water. It is supplied in a glass ampule with 500 mg of fluorescein sodium 
in 5 mL of water. The dye is injected intravenously and is stimulated by blue light (Woods 
lamp) in the range of 465 to 490 nm. Under the blue light, it will fluoresce as a bright yellow-
green color. 
b. Manufacturing and Formulation: Fluorescein 500mg/5mL is a sterile solution containing 
fluorescein sodium for intravenous injection. It is manufactured by multiple companies 
including Alcon Chemical (Fluorescite). Each 1.0 mL of solution contains 100 mg fluorescein 
sodium. One ampoule of 5mL contains 500 mg fluorescein sodium. 
 
Excipients: Sodium hydroxide for pH adjustment, water for injections. 
 
c. 
Preparation:  Comes packaged as a single ampule containing 5 cc of fluorescein dye. 
 
d. 
Dosing Administration or Utilization: One ampule (5 cc) injected intravenously prior to 
ligation of the uterine arteries. 
 
e. 
Storage and Disposition: Fluorescein ampules should be stored between 5oC to 25oC. 
 
f. 
Label Information: See Appendix I: Manufacturer’s label 
 
g. 
Agent Ordering: Fluorescein dye will be purchased by Pharmacy for this study, and the 
Division of Gynecologic Oncology will reimburse pharmacy as subjects complete the study. 
 
h. 
Agent Accountability: UAMS Pharmacy Department 
 

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9. TREATMENT PLAN 
 
a. On-Study Evaluation:  
 
After signing the IRB-approved informed consent form, research participants will be 
registered by a clinical research associate (CRA) in the Cancer Clinical Trials Office (CCTO).  
Upon registration, surgery will be scheduled at the next available surgery time slot.  All 
research participants will receive fluorescein injection through their existing intravenous line 
during their operative procedure  for endometrial cancer staging.  This will consist of one 
ampule (5 cc) injected intravenously prior to ligation of the uterine arteries. After the uterus is 
removed it will be sent to surgical pathology for evaluation as per routine care. The 
pathologist will open the uterus and evaluate the endometrium. He or she will then cut into 
the myometrium in an area most suspicious for invasion. The cross section of the 
myometrium and endometrium will be photographed while exposed to a Woods lamp. The 
normal myometrium will have a yellow fluorescent appearance under the Woods lamp. The 
cancerous tissue will have minimal fluorescence. The measurement will be taken estimating 
the depth of invasion of the cancer into the myometrium on the basis of its physical 
appearance under the Woods lamp.  Cross-sectioning of the uterus is routine procedure by 
pathology for the intra-operative evaluation of endometrial cancer.  This information routinely 
is provided in order to determine if lymph node staging is necessary. 
 
 
The area that was measured and photographed will then be prepared for a frozen section to 
document depth of invasion. This is the standard procedure performed during an endometrial 
staging. The depth of invasion on the frozen section will be recorded. This same area will 
undergo histologic confirmation by permanent pathology to determine depth of invasion.  The 
frozen section is part of routine standard of care in evaluation of endometrial cancer. 
 
 
Subjects will be informed prior to participation in this study that they will have a bright yellow 
discoloration of their urine and possibly a mild yellow discoloration of their skin for up to 24 
hours after the procedure. 
 
b. Dose Assignment:   This is a single arm study.  A single dose of Fluorescein will be 
administered to all subjects in this study. 
c. Specimen Handling:  The uterus will be sent to pathology immediately after its removal from 
the patient. The study pathologist will be informed when to expect a subject specimen and 
will prepare the lab for Woods lamp evaluation, measurement and photography. The 
remainder of the specimens from the procedure will be processed in the usual manner for 
routine pathology evaluations. 
 
Visit Breakdown 
 
1. 
Informed consent will be obtained at the pre-operative surgery appointment. 
 
 
2. 
Urine Pregnancy test (only for women of child bearing potential and only if a previous 
urine pregnancy exam has not been performed within 28 days of consent as standard of 
care) 
 
 
3. 
Injection with the fluorescent dye will occur approximately 5 to 10 min. prior to ligation of 
the uterine vessels during the hysterectomy. 

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4. 
The uterus will be sent to pathology immediately after its removal where Woods lamp 
evaluation, measurement and photography will be performed.  
 
d. Prohibited Medications: none 
 
e. Dose Limiting Criteria: none 
 
10. STUDY CALENDAR 
 
 
TEST/EVENT 
 
VISITS 
 
Pre-Operative 
visit 
Surgery 
Informed Consent 
X 
 
Inclusion/Exclusion Criteria 
X 
 
Urine Pregnancy exam 
X 
 
Flourescent dye injection 
 
X 
Pathology review 
 
X 
Adverse Event Assessment 
 
X 
 
11. RISKS AND TOXICITIES TO BE MONITORED 
 
Potential Toxicities, Risks and Precautions 
 
a. 
G.I. Nausea can occur in up to 10% of patients however vomiting is uncommon and 
abdominal pain is rare. 
b. 
Nervous system. Syncope has been reported between 1 and 10% of patients. There have 
been very rare reports of convulsions. 
c. 
Allergic reaction. Hypersensitivity reactions can occur after injection and may be as severe 
as anaphylaxis. Fatal anaphylactic reaction is reported in 1 of 220,000 angiographies. 
d.  Skin. Urticaria and pruitis can frequently occur after injection.  
The above side effects will be unlikely to occur given that the injection is done while the patient is 
under general anesthesia.  If there is any evidence of hypersensitivity, the  anesthesiologists can 
utilize antihistamine agents to reduce the duration and severity of the hypersensitivity. 
 

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Benefits 
There will be no direct benefit to the patient for participation in this study. However, this study 
may help to identify a less expensive and more rapid method of detecting the extent of 
endometrial cancer invasion at the time of staging. This could be a benefit in the future for 
determining which women require lymphadenectomy in which do not. 
12. DATA HANDLING AND RECORD KEEPING 
 
a. Registration Procedures: After consent has occurred and eligibility criteria has been 
completed, subjects must be registered with the CCTO before enrollment to the study. 
Patients are registered by the Research staff calling the CCTO Office Monday through 
Friday, 8:00 AM - 4:30 PM. Prior to registration, eligibility criteria must be confirmed by the 
research staff.  
b. Confidentiality and De-Identification of Data: Upon registration, the subject will be 
assigned a unique identifying code or number to which the subject will be identied by.  All 
subject related materials will be identified by that subject’s unique identifying code or number.  
Only the Research staff will have access to the code/number and information that identifies 
the subject in this study. 
 
c. Methods for Data Collection and Data Collection Tools: Data will be entered into 
OpenClinica through electronic web-based case report forms (CRFs).   OpenClinica is a 
secure open source system for electronic data capture and clinical data management. Data 
will be stored electronically on encrypted computers. Data collection from this study will be 
limited to the pathologic findings at the time of endometrial cancer staging. 
 
d. Storage of Study Related Items : This study’s documents will be retained for a minimum of 
three years after study completion. 
 
13. SPECIMEN STORAGE AND DISPOSAL 
 
Solid tissues will be embedded into paraffin and are stored at room temperature as part of 
standard pathology evaluation. There will not be a study-specific specimen retained. 
Photographs of the stained endometrial cancer and myometrium will be retained for purposes of 
comparison in this study. 
 
14. STATISTICAL CONSIDERATIONS 
 
a. 
Sample Size and Study Duration: 100 subjects will be entered into this pilot study. It is 
estimated that this study will be completed in less than one year. 
 

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b. 
Study Endpoints:  Invasion depth as determined using each of three methods: Systemic 
Fluorescein Injection (SFI), Frozen Section (FS), and Permanent Section (PS).     
 
c. Data Analysis Plan: The primary objective is basically to determine whether the SFI method 
works.  Provided that it works, the analysis plan in support of the Secondary Objective is as 
follows:  For each study subject, the paired difference in invasion depths determined using 
the SFI versus FS methods will be calculated and expressed as a percentage of the FS-
based invasion depth.  Likewise, the paired difference in invasion depths determined using 
the SFI versus PS methods will be calculated and expressed as a percentage of the PS-
based invasion depth.  Each type of paired difference will be summarized as the mean and 
standard deviation.  Because PS is considered the definitive “gold standard” of determining 
invasion depth, the mean of the paired differences between SFI and PS methods will be 
compared against equivalence limits of –25% and +25% via theTwo One-Sided Tests 
(TOST) procedure using an alpha=0.10 significance level.  If this mean is significantly “in 
between” both equivalence limits, then this will indicate that the discrepancy in invasion 
depths between SFI and PS is significantly less than 25%, and we will accordingly consider 
further investigation of the SFI method of determining invasion depth.   
 
Sample Size and Power:  When two methods are equivalent, the mean of their paired 
difference will be 0%.  The power of the TOST procedure to declare that a mean of 0% is 
significantly “in between” equivalence limits of –25% and +25% depends heavily on the 
standard deviation of the paired difference when the sample size is fixed at 20 subjects.  A 
simulation study using 1,000,000 simulations in PASS 12 software indicates that 20 subjects 
gives the TOST procedure >90% power at 10% alpha to declare a mean of 0% to be 
significantly “in between” the above-stated equivalence limits provided that the standard 
deviation of the paired differences is less than 37%.  This power calculation shows that, if SFI 
agrees well with PS, then 20 subjects should provide our study with sufficient power to 
demonstrate that fact.       
 
d. 
Missing, Unused and Spurious Data: Missing data will be treated as missing, and will not 
be imputed.  Spurious data will be corrected at the source document.  Any data documented 
as spurious that is unable to be corrected at the source will be treated as missing.   
15. ETHICAL AND REGULATORY CONSIDERATIONS 
 
The following must be observed to comply with FDA regulations for the conduct and monitoring 
of clinical investigations. The following also represents sound research practice. All study 
personnel must have completed training in good clinical practice (GCP) and protection of human 
subjects. 
 
a. 
Recruitment and Informed Consent: Patients with endometrial cancer will be identified in 
the UAMS gynecologic cancer clinic during routine clinic appointments by their providers. 
Upon identification, the patient will be informed of the study by their physician along with the 
research staff. The patient will be allowed to review the IRB-approved informed consent 
form, and if they would like to participate in the study, they will be presented the informed 
consent form. During the consent process, the patient will be clearly informed of the fact that 
participation in this study is voluntary and that the decision to not participate in the study will 
have no effect on future clinical care. The patient will be encouraged to have family or 

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friends participate in any or all of the process. The patient will be provided sufficient time to 
ask questions, and will be questioned to be ensure they understand the information. If the 
patient agrees to proceed, they will sign consent. The consent process will be documented 
in the medical record. A copy of the informed consent document will be given to the 
research paricipant, and additional copies will be sent to the medical records department. 
The original informed consent will be filed with the subject file in CCTO. The principles of 
informed consent are described by the Federal Regulatory Guidelines: Code of Federal 
Regulations (21CFR50) and the Office for Human Research Protections: Protection of 
Human Subjects (45CFR46). These principles must be followed to comply with Food and 
Drug Administration (FDA) regulations for the conduct and monitoring of clinical 
investigations.  
 
b. Institutional Review: This study will be approved by the UAMS Institutional Review Board 
(IRB) as defined by Federal Regulatory Guidelines 21CFR56 and the Office for Human 
Research Protections: Protection of Human Subjects 45CFR46. This study will also undergo 
scientific review by the Cancer Institute’s Protocol Review and Monitoring Committee 
(PRMC). Approval by both the IRB and PRMC is required before the clinical trial can be 
activated.   
 
c. 
Investigational Agent Accountability: Fluroescein for this study will be stored in the main 
inpatient pharmacy and will be ordered from there and sent to the operating room pharmacy 
for pick up.  Fluorescein dye will be purchased by Pharmacy for this study, and the Division 
of Gynecologic Oncology will reimburse pharmacy as subjects complete the study.   
 
16. ADVERSE EVENTS 
 
a. Expedited Reporting:  
• 
The Principal Investigator (PI) must be notified within 24 hours of learning of any serious 
adverse events (SAEs), regardless of attribution, occurring during the study. 
• 
The UAMS IRB must be notified within 10 business days of “any unanticipated problem 
involving risk to subject or others (UPR/UPIRTSO).”  
• 
For UPR/UPIRTSO, see UAMS IRB Policy 10.2. 
b. Routine Reporting: All other AEs, such as those that are expected, or are unlikely or 
definitely not related to the study participation, are to be reported annually as part of regular data 
submission. 
17. MONITORING 
 
a. 
Medical Monitor: The Medical Monitor, Principal Investigator and study staff will meet 
quarterly, once the PI has monitored the data, to review safety data (adverse events, 
serious adverse events and other scientific observations). 
 
b. 
Data Monitor: The study will be monitored by the Principal Investigator to ensure that the 
rights and well-being of human subjects are protected, that the data are accurate, complete 

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and verifiable from source documents and that the trial is conducted in compliance with 
currently approved protocol/amendments. 

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18. BIBLIOGRAPHY 
 
1. Paral, J., Ferko, A., Plodr, M., Raupach, J., Hadzi-Nikolov, D., Dolezal, D. et al. (2007). 
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2. Jones, N. F., Kuzon, W. M., Jr., Shestak, K. C., & Roth, A. G. (1994). Use of fluorescein to 
predict survival of a free jejunal transfer after disruption of the arterial pedicle on postoperative 
day 12. Br J Plast.Surg, 47, 375-377. 
3. Ballard, J. L., Stone, W. M., Hallett, J. W., Pairolero, P. C., & Cherry, K. J. (1993). A critical 
analysis of adjuvant techniques used to assess bowel viability in acute mesenteric ischemia. Am 
Surg, 59, 309-311. 
4. Holmes, N. J., Cazi, G., Reddell, M. T., Gorman, J. H., Fedorciw, B., Semmlow, J. L. et al. 
(1993). Intraoperative assessment of bowel viability. J Invest Surg, 6, 211-221. 
5. Horgan, P. G. & Gorey, T. F. (1992). Operative assessment of intestinal viability. Surg Clin 
North Am, 72, 143-155. 
6. Bergman, R. T., Gloviczki, P., Welch, T. J., Naessens, J. M., Bower, T. C., Hallett, J. W., Jr. 
et al. (1992). The role of intravenous fluorescein in the detection of colon ischemia during aortic 
reconstruction. Ann Vasc Surg, 6, 74-79. 
7. Marzella, L., Brotman, S., Mayer, J., & Cowley, R. A. (1984). Evaluation of injured intestine 
with the aid of fluorescein. Am Surg, 50, 599-602. 
8. Carter, M. S., Fantini, G. A., Sammartano, R. J., Mitsudo, S., Silverman, D. G., & Boley, S. 
J. (1984). Qualitative and quantitative fluorescein fluorescence in determining intestinal viability. 
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9. Mann, A., Fazio, V. W., & Lucas, F. V. (1982). A comparative study of the use of fluorescein 
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10. Bulkley, G. B., Zuidema, G. D., Hamilton, S. R., O'Mara, C. S., Klacsmann, P. G., & Horn, S. 
D. (1981). Intraoperative determination of small intestinal viability following ischemic injury: a 
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standard clinical judgment. Ann Surg, 193, 628-637. 
11. Misas, J. E., Cold, C. J., & Hall, F. W. (1991). Vulvar Paget disease: fluorescein-aided 
visualization of margins. Obstet Gynecol, 77, 156-159. 
12. Magrina, J. F. & Masterson, B. J. (1981). Evaluation of groin and vulvar flap viability by the 
use of intravenous fluorescein. Gynecol Oncol, 11, 96-101. 

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13. Losken, A., Styblo, T. M., Schaefer, T. G., & Carlson, G. W. (2008). The use of fluorescein 
dye as a predictor of mastectomy skin flap viability following autologous tissue reconstruction. 
Ann Plast.Surg, 61, 24-29. 
14. Morykwas, M. J., Hills, H., & Argenta, L. C. (1991). The safety of intravenous fluorescein 
administration. Ann Plast.Surg, 26, 551-553. 
15. Wahner, H. W. (1988). Assessment of the viability of skin grafts. Semin Nucl.Med, 18, 255-
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16. Smith, J. A., Jr. & Middleton, R. G. (1979). The use of fluorescein in radical inguinal 
lymphadenectomy. J Urol., 122, 754-756. 
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APPENDIX I 
 
 

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