NL-OMON25423
Recruiting
Not Applicable
A randomized controlled trial to compare near-infrared fluorescence imaging with standard-of-care sentinel lymph node mapping in vulvar cancer patients
eiden University Medical Center (LUMC)0 sites48 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- eiden University Medical Center (LUMC)
- Enrollment
- 48
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
- 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.
- 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
Investigators
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Not specified
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