Clinical trial NCT06035068: SLN Mapping and ICG Dye for Vulvar Cancer
Official title: Sentinel Lymph Node Mapping and Detection With Indocyanine Green and Spy-Phi Handheld Camera Technology in Early-Stage Vulvar Cancer (PILOT)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Vulva Cancer
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 10 participants fitting the above criteria at Tufts Medical Center

Brief summary: Doctors typically use blue dye to assist in locating and extracting lymph nodes for biopsy. However, this process can prove somewhat challenging for both patients and medical teams due to its need for extensive coordination and the assistance of a nuclear medicine team. Some studies have talked about using a different method to find these lymph nodes using a special dye called Indocyanine Green (ICG). This method involves shining a special camera on the skin. So far, no studies have directly compared the ICG method to the standard blue dye. The ICG camera could make things easier for patients and doctors, and more patients might choose to have their lymph nodes checked with this new method. The goal of our study is to see if using the ICG dye is just as good as the standard method of blue dye.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Patients with early-stage SCC (diameter \<4 cm) of the vulva without suspicious lymph nodes at palpation or imaging who are planned for surgery at Tufts Medical Center.
* Patients with squamous cell carcinoma, depth of invasion \> 1mm
* Patients with T1 or T2 tumors (FIGO staging) \< 4 cm, not encroaching in urethra or anus with clinically negative inguinofemoral lymph nodes
* Localization and size of the tumor are such that perilesional injection of the tracers at three or four sites is possible
* Preoperative imaging do not show enlarged (\<1.5 cm)/ suspicious nodes
* Willing and able to give informed consent

Exclusion Criteria:

* Inoperable tumors and tumors with diameter \> 4 cm
* Patients with inguinofemoral lymph nodes that are palpable on clinical exam suspicious for metastases or with cytologically proven inguinofemoral lymph node metastases
* Radiologically enlarged (\>1.5 cm) inguinofemoral lymph nodes
* Patients with multifocal tumors
* Pregnancy

Primary outcomes:
measure: Detection Rate of SLNs using ICG Dye vs Blue Dye at Patient Level
timeFrame: Data collection at time of surgery
measure: Clustered Analysis at the Hemi-Pelvis Level
timeFrame: Data collection at time of surgery
measure: 3. Difference in SLNs Detected in Blue vs Green Dye when Data is Clustered at Hemi-Pelvis Level
timeFrame: Data collection at time of surgery
Secondary outcomes:
measure: Sensitivity, Specificity, and Negative Predictive Value of ICG Dye vs Standard Blue Dye
timeFrame: Data collection at time of surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Rafael Gonzalez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Te Grootenhuis NC, van der Zee AG, van Doorn HC, van der Velden J, Vergote I, Zanagnolo V, Baldwin PJ, Gaarenstroom KN, van Dorst EB, Trum JW, Slangen BF, Runnebaum IB, Tamussino K, Hermans RH, Provencher DM, de Bock GH, de Hullu JA, Oonk MH. Sentinel nodes in vulvar cancer: Long-term follow-up of the GROningen INternational Study on Sentinel nodes in Vulvar cancer (GROINSS-V) I. Gynecol Oncol. 2016 Jan;140(1):8-14. doi: 10.1016/j.ygyno.2015.09.077. Epub 2015 Sep 30.
citation: Covens A, Vella ET, Kennedy EB, Reade CJ, Jimenez W, Le T. Sentinel lymph node biopsy in vulvar cancer: Systematic review, meta-analysis and guideline recommendations. Gynecol Oncol. 2015 May;137(2):351-61. doi: 10.1016/j.ygyno.2015.02.014. Epub 2015 Feb 20.
citation: Hutteman M, van der Vorst JR, Gaarenstroom KN, Peters AA, Mieog JS, Schaafsma BE, Lowik CW, Frangioni JV, van de Velde CJ, Vahrmeijer AL. Optimization of near-infrared fluorescent sentinel lymph node mapping for vulvar cancer. Am J Obstet Gynecol. 2012 Jan;206(1):89.e1-5. doi: 10.1016/j.ajog.2011.07.039. Epub 2011 Jul 30.
citation: Crane LM, Themelis G, Arts HJ, Buddingh KT, Brouwers AH, Ntziachristos V, van Dam GM, van der Zee AG. Intraoperative near-infrared fluorescence imaging for sentinel lymph node detection in vulvar cancer: first clinical results. Gynecol Oncol. 2011 Feb;120(2):291-5. doi: 10.1016/j.ygyno.2010.10.009. Epub 2010 Nov 6.