A randomized controlled trial to compare near-infrared fluorescence imaging with standard-of-care sentinel lymph node mapping in vulvar cancer patients

Recruiting

Conditions: Vulvar carcinoma, sentinel node mapping, ICG, fluorescence imaging

Registration Number: NL-OMON25423

Lead Sponsor: eiden University Medical Center (LUMC)

Brief Summary: Crane LM, Themelis G, Arts HJ et al. Intraoperative near-infrared fluorescence imaging for sentinel lymph node detection in vulvar cancer: first clinical results. Gynecol Oncol 2011;120:291-295.<br> - Schaafsma BE, Verbeek FP, Peters AA et al. Near-infrared fluorescence sentinel lymph node biopsy in vulvar cancer: a randomised comparison of lymphatic tracers. BJOG 2013;120:758-764.<br> - Hutteman M, van der Vorst JR, Gaarenstroom KN et al. Optimization of near-infrared fluorescent sentinel lymph node mapping for vulvar cancer. Am J Obstet Gynecol 2012;206:89-5

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 48

Inclusion Criteria

• T1 squamous cell carcinoma of the vulva (FIGO staging 2009), with a depth of infiltration >1 mm, <4 cm in diameter, unifocal and not encroaching in urethra, vagina or anus, with clinically negative inguinofemoral LNs;

• Localization and size of the tumor are such that peri-lesional injection of the tracer at 3 or 4 sites is possible;

Exclusion Criteria

• Patients with multifocal tumors of the vulva;

• Patients who show enlarge (>1.5cm)/suspicious lymph nodes at preoperative imaging;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of intraoperative visualized SLNs in vulvar cancer patients who receive standard-of-care SLN mapping using 99mTc and patent blue compared to patients who receive a pre-operative injection of ICG:99mTc without patent blue.

Secondary Outcome Measures

Name	Time	Method
1. Correlation between NIR fluorescent, or blue and radioactive SLNs;<br /><br>2. Identification & resection rate of SLNs and non-SLNs;<br /><br>3. Non-invasive (percutaneous) lymphatic vessel and SLN identification in case of NIR fluorescence imaging;<br /><br>4. Several time intervals during surgery, such as time until SLN identification, time until SLN resection and total time of the procedure;<br /><br>5. Number of failures to find the SLN; difference in number of LNs on lymphoscintigraphy and intra-operative SLN detection;<br /><br>6. Size of skin incision used for SLN biopsy;<br /><br>7. Number of positive resection margins (i.e. R1 resection) in both groups;<br /><br>8. Evaluation of the SLN procedure by the surgeon by a short questionnaire;<br /><br>9. Short-term morbidity, defined as wound breakdown/wound infection and lymphocyst formation <6 weeks after surgery;<br /><br>10. Long-term morbidity, defined as lymphedema and recurrent cellulitis >6 weeks after surgery until 1 year.