Clinical trial NCT01075412: FLT PET Imaging for Cervical Cancer
Official title: 'F-18 Fluorothymidine ([18F]FLT) PET Imaging for Early Evaluation of Response to Chemoradiation Therapy in Patients With Cervical Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Uterine Cervical Neoplasms
Keywords: Positron-Emission Tomography
Radiotherapy, Intensity-Modulated
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Holden Comprehensive Cancer Center
First posted: 2010-02-25
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our primary hypothesis is that \[18F\]FLT PET can identify active bone marrow in addition to metabolically active tumor.

This trial will use FLT-PET imaging to define areas of active bone marrow in the pelvis. The radiation plan is then designed to spare that area, in hopes of keeping the bone marrow active during therapy. Bone marrow and tumor activity will be monitored using a sequence of FLT PET scans during the course of chemotherapy and radiation therapy.

Detailed description: Subjects will undergo a total of up to 5 FLT PET scans.

Subjects are randomized between two groups to reduce radiation exposure from the FLT PET scans. If bone marrow activity is not identified in one scan, further scans are cancelled until the 1-month follow up scan. This is not a randomization to compare therapeutic efficacy between two study arms. Data will be pooled for analysis as pre-specified in the study's statistical plan.

Group 1 has FLT PET scans pretreatment, after 5 radiation treatments, after 10 radiation treatments, after 15 radiation treatments, and then 1 month after completing radiation therapy.

Group 2 has FLT PET scans pretreatment, after 5 radiation treatments, after 10 radiation treatments, after 20 radiation treatments, and then 1 month after completing radiation therapy.

Eligibility criteria: Inclusion Criteria:

* Ability to understand and willingness to sign a written informed consent document.
* Histologically confirmed stage IB2, IIA, IIB, IIIB, and IVA squamous cell carcinoma of the cervix.
* Scheduled to receive chemo-radiation for oncologic treatment.
* Karnofsky of at least 60 at time of screening
* Life expectancy of at least 6 months.
* Leukocytes at least 3,000/microL
* absolute neutrophil count at least 1,500/microL
* platelets at least 100,000/microL
* total bilirubin at maximum 1.0 mg/dL (UIHC limit of normal)
* either ALT or AST less than 2.5 times the upper limit of normal
* creatinine less than 1.5 times the upper limit of normal
* non-pregnant, non-nursing, willing to use contraception

Exclusion Criteria:

* oncology research protocol requiring full pelvic radiation (i.e., 4-field box technique) or experimental chemotherapy
* uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.
* subjects taking nucleoside analog medications such as those used as antiretroviral agents.
* patients who have undergone hysterectomy or will have a hysterectomy as part of their cancer therapy.

Primary outcomes:
measure: Percent Difference From Baseline IMRT Plan (%)
timeFrame: Baseline (pre-treatment)
Secondary outcomes:
measure: Chemotherapy Compliance
timeFrame: post-treatment
measure: Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
timeFrame: baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment
measure: Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
timeFrame: baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment
measure: Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
timeFrame: baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment
measure: Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
timeFrame: baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Holden Comprehensive Cancer Center
state: Iowa
Study officials:
affiliation: University of Iowa
name: Michael M Graham, Ph.D., M.D.
role: STUDY_DIRECTOR
affiliation: University of Iowa
name: Sarah McGuire, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: McGuire SM, Menda Y, Ponto LL, Gross B, Juweid M, Bayouth JE. A methodology for incorporating functional bone marrow sparing in IMRT planning for pelvic radiation therapy. Radiother Oncol. 2011 Apr;99(1):49-54. doi: 10.1016/j.radonc.2011.01.025. Epub 2011 Mar 22.
citation: McGuire SM, Menda Y, Boles Ponto LL, Gross B, Buatti J, Bayouth JE. 3'-deoxy-3'-[(1)(8)F]fluorothymidine PET quantification of bone marrow response to radiation dose. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):888-93. doi: 10.1016/j.ijrobp.2010.12.009. Epub 2011 Feb 6.
citation: Menda Y, Ponto LL, Dornfeld KJ, Tewson TJ, Watkins GL, Gupta AK, Anderson C, McGuire S, Schultz MK, Sunderland JJ, Graham MM, Buatti JM. Investigation of the pharmacokinetics of 3'-deoxy-3'-[18F]fluorothymidine uptake in the bone marrow before and early after initiation of chemoradiation therapy in head and neck cancer. Nucl Med Biol. 2010 May;37(4):433-8. doi: 10.1016/j.nucmedbio.2010.02.005.
citation: McGuire SM, Bhatia SK, Sun W, Jacobson GM, Menda Y, Ponto LL, Smith BJ, Gross BA, Bayouth JE, Sunderland JJ, Graham MM, Buatti JM. Using [(18)F]Fluorothymidine Imaged With Positron Emission Tomography to Quantify and Reduce Hematologic Toxicity Due to Chemoradiation Therapy for Pelvic Cancer Patients. Int J Radiat Oncol Biol Phys. 2016 Sep 1;96(1):228-39. doi: 10.1016/j.ijrobp.2016.04.009. Epub 2016 Apr 19.
citation: McGuire SM, Menda Y, Ponto LLB, Gross B, TenNapel M, Smith BJ, Bayouth JE. Spatial mapping of functional pelvic bone marrow using FLT PET. J Appl Clin Med Phys. 2014 Jul 8;15(4):129-136. doi: 10.1120/jacmp.v15i4.4780.