Vulvar Cancer
Conditions
Keywords
Near-Infrared Imaging, Indocyanine Green, Sentinel Lymph Nodes, 23-310
Brief 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.
Interventions
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
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 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| success of identifying the SLN | 18 months | by use of near-infrared imaging with ICG injection. Patients will be eligible for assessment if they undergo attempted SLN mapping by lymphoscintigraphy and near-infrared imaging with ICG injection. The primary endpoint is the accurate identification of the SLN, defined as the uptake of ICG in the proximalmost draining lymph node in the inguinofemoral chain. Evaluate the ability of near-infrared imaging with ICG injection to detect the inguinofemoral SLN in patients with early-stage vulvar cancer, compared with radiocolloid lymphoscintigraphy, the current standard. |
Countries
United States
Outcome results
None listed