Trial Title:
Study of Near-Infrared Imaging With Indocyanine Green for Detection of Sentinel Lymph Nodes in People With Vulvar Cancer
NCT ID:
NCT06127836
Condition:
Vulvar Cancer
Conditions: Official terms:
Vulvar Neoplasms
Conditions: Keywords:
Near-Infrared Imaging
Indocyanine Green
Sentinel Lymph Nodes
23-310
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
This is a prospective study to evaluate the performance of near-infrared imaging with ICG
injection, compared with lymphoscintigraphy, for the detection of the inguinofemoral SLN
in patients with vulvar cancer.
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Masking description:
Surgeons will be blinded to the results of the lymphoscintigraphy and will perform SLN
biopsy in the operating room using near-infrared imaging with ICG injection. And the
results will not be released until the consenting surgeon contacts the Nuclear Medicine
team after attempting to identify the SLN by use of near-infrared imaging with ICG
injection.
Intervention:
Intervention type:
Procedure
Intervention name:
ICG guided sentinel lymph node biopsy
Description:
The surgeon will subsequently inject ICG in accordance with the SLN protocol in the
operating room and will identify and remove the SLN by use of near-infrared imaging
guidance only. Once the surgeon has identified the SLN in this way, he or she will be
unblinded to the results of the lymphoscintigraphy and will use the results of
preoperative imaging and an intraoperative gamma counter to confirm the SLNs.
Arm group label:
patients undergoing preoperative lymphoscintigraphy
Summary:
The purpose of this study is to compare two types of imaging for sentinel lymph node
(SLN) mapping in people with early-stage vulvar cancer. The researchers will compare
indocyanine green near-infrared (ICG-NIR) imaging with lymphoscintigraphy. All
participants in this study will be scheduled for standard surgical treatment at Memorial
Sloan Kettering Cancer Center (MSK). This surgical treatment includes SLN mapping (with
both lymphoscintigraphy and ICG-NIR imaging) and SLN biopsy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- ≥18 years of age
- Newly diagnosed with vulvar cancer and scheduled to undergo SLN biopsy (patients
with squamous cell carcinomas and melanomas will be included)
- Primary tumor ≤4 cm in size
- For patients with squamous cell carcinoma, >1 mm of invasion is required
Exclusion Criteria:
- Clinically or radiographically enlarged inguinofemoral lymph nodes (if imaging is
performed)
- Presence of distant metastases
- Absolute contraindication to radiocolloid Tc-99 or ICG
- Nonsquamous or nonmelanoma histologic subtype
Gender:
Female
Gender based:
Yes
Gender description:
Vulvar cancer
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vance Broach, MD
Phone:
212-639-6876
Facility:
Name:
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vance Broach, MD
Phone:
212-639-6876
Facility:
Name:
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vance Broach, MD
Phone:
212-639-6876
Facility:
Name:
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vance Broach, MD
Phone:
212-639-6876
Facility:
Name:
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vance Broach, MD
Phone:
212-639-6876
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vance Broach, MD
Phone:
212-639-6876
Contact backup:
Last name:
Mario Leitao, MD
Phone:
212-639-3987
Investigator:
Last name:
Vance Broach, MD
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vance Broach, MD
Phone:
212-639-6876
Facility:
Name:
Houston Methodist Cancer Center (Data Collection Only)
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Anuj Suri, MD, FACOG
Phone:
713-441-1026
Start date:
November 6, 2023
Completion date:
November 2026
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06127836
http://www.mskcc.org/mskcc/html/44.cfm
