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van CCT (UK)


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


- candidate number30498
- NTR NumberNTR7685
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-dec-2018
- Secondary IDsP09.001 Addendum 17
- Public TitleA randomized controlled trial to compare near-infrared fluorescence imaging with standard-of-care sentinel lymph node mapping in vulvar cancer patients
- Scientific TitleA randomized controlled trial to compare near-infrared fluorescence imaging with standard-of-care sentinel lymph node mapping in vulvar cancer patients
- ACRONYM
- hypothesisPeritumoral injections of combined ICG:99mTc may be superior to standard-of-care and may facilitate the SLN procedure by real time near-infrared intra-operative guidance.
- Healt Condition(s) or Problem(s) studiedVulvar cancer, Sentinel lymph node localization, ICG, Fluorescence imaging
- 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;
Normal kidney function (eGFR >55);
Absence of any physiological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;
Age ≥ 18 years;
Written informed consent must be given according to ICH/GCP, national and local regulations.
- Exclusion criteria Patients with multifocal tumors of the vulva;
Patients who show enlarge (>1.5cm)/suspicious lymph nodes at preoperative imaging;
Patients with a history of vulvar cancer or previously performed SLN procedure/groin operation that might hamper SLN identification;
Allergy to iodine, patent blue, shellfish or ICG;
Pregnancy.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 22-jun-2016
- planned closingdate1-jan-2020
- Target number of participants48
- InterventionsPatients will be randomized by computer into 2 groups. Standard-of-care SLN mapping implies 3-4 peritumoral intracutaneous injections of approximately 0.5ml 30-100MBq 99mTc-nanocolloid 3-24 hours before surgery. After general or locoregional anesthesia, prior to the first groin incision, 1-2 mL of patent blue V will be injected peritumorally. The second group of patients will receive 3-4 peritumoral intracutaneous injections of ICG:99mTc (also 30-100MBq 99mTc-nanocolloid in total) 3-24 hours before surgery, given by the Nuclear Department or by the Gynaecologist. Intraoperatively, it will be attempted to visualize SLNs. In case the SLN cannot be found in the second group of patients, patent blue will be administered as well. Postoperatively, short and long term morbidity will be registered in all patients, as defined by the endpoints.
- Primary outcomeThe 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 outcome1. Correlation between NIR fluorescent, or blue and radioactive SLNs;
2. Identification & resection rate of SLNs and non-SLNs;
3. Non-invasive (percutaneous) lymphatic vessel and SLN identification in case of NIR fluorescence imaging;
4. Several time intervals during surgery, such as time until SLN identification, time until SLN resection and total time of the procedure;
5. Number of failures to find the SLN; difference in number of LNs on lymphoscintigraphy and intra-operative SLN detection;
6. Size of skin incision used for SLN biopsy;
7. Number of positive resection margins (i.e. R1 resection) in both groups;
8. Evaluation of the SLN procedure by the surgeon by a short questionnaire;
9. Short-term morbidity, defined as wound breakdown/wound infection and lymphocyst formation <6 weeks after surgery;
10. Long-term morbidity, defined as lymphedema and recurrent cellulitis >6 weeks after surgery until 1 year.
- TimepointsEnd of the trial.
- Trial web site-
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD PhD K.N. Gaarenstroom
- CONTACT for SCIENTIFIC QUERIESMD PhD K.N. Gaarenstroom
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- Publications- 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
- Brief summaryA phase II, randomized controlled trial to determine the efficacy of identification of SLN(s) in vulvar cancer patients by standard-of-care compared to near-infrared (NIR) fluorescence imaging. Standard-of-care SLN mapping consists of preoperative peritumoral injections of 99mTc-nanocolloid and during surgery a peritumoral injection of patent blue. Patients who undergo NIR fluorescence imaging will receive a preoperative injection of indocyanine green (ICG) premixed with 99mTc-nanocolloid (ICG:99mTc). During the surgical procedure NIR fluorescence imaging will be performed. Patent blue will only be injected when the SLN cannot be identified by NIR fluorescence imaging, to give the patient standard-of-care.
- Main changes (audit trail)
- RECORD25-dec-2018 - 2-jan-2019


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