NL-OMON54845
Recruiting
Not Applicable
Sentinel lymph node procedure in patients with recurrent vulvar squamous cell carcinoma. A multicentre observational study. - Sentinel Node Procedure in Recurrent Vulvar Carcinoma.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 243
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •In order to be eligible for the study (non SLN cohort and SLN cohort, group
- •A\-C): \- Possible to understand and read Dutch. \- Possible to understand the
- •study and give informed consent. \- No age limit specified. \- Patients should
- •mentally, physically and geographically be able to undergo follow\-up. In order
- •to be eligible to undergo the SLN procedure, a subject must meet all of the
- •following criteria: \- First local recurrent SCC of the vulva. \- Previous
- •treatment with wide local excision or (partial) vulvectomy tumours \< 4 cm., not
- •encroaching in urethra, vagina or anus with clinically negative inguinofemoral
- •lymph nodes. \- Localisation and size of the tumour are such that perilesional
- •injection of the tracers at three or four sites is possible. \- Preoperative
Exclusion Criteria
- •Potential subject who meets any of the following criteria should not undergo
- •the SLN procedure in the study arm (A\-B), the patient can be asked for the non
- •SLN cohort. \- Inoperable tumours and tumours with diameter \> 4 cm. \- Patients
- •with inguinofemoral lymph nodes at palpation clinically suspect for metastases,
- •at radiology enlarged (\> 10 mm short axis) / suspicious groin nodes and with
- •cytological proven inguinofemoral lymph node metastases. \- A history of
- •bilateral IFL and radiotherapy to the groins. \- A lateral tumour and history of
- •ipsilateral IFL and ipsilateral radiotherapy. \- Tumour encroaching urethra,
- •vagina, or anus. \- Previous surgery of the vulva was not radical (margin \< 1
- •mm) and additional treatment (2nd surgery or radiotherapy) was not performed. \-
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not yet recruiting
Not Applicable
Sentinel lymph node procedure in patients with recurrent vulvar squamous cell carcinoma. A multicentre observational study.NL-OMON22671Erasmus MC150
Not yet recruiting
Not Applicable
In vivo sentinel node procedure in patients with resectable colon cancer, a pilot study.colon cancerlarge bowel cancer100179901001799110017998NL-OMON33423Academisch Medisch Centrum30
Active, not recruiting
Phase 1
Sentinel lymph node biopsy in patients with parotid gland carcinoma using a combination of 99mTc-nanocolloid and 68Ga-tilmanocept PET/CT: A feasibility study. (SNparotis)Carcinoma of the parotid glandMedDRA version: 21.1Level: LLTClassification code: 10026329Term: Malignant neoplasm of parotid gland Class: 10029104Therapeutic area: Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]CTIS2024-514233-37-00niversitair Medisch Centrum Utrecht10
Completed
Phase 3
Sentinel lymph node biopsy after neoadjuvant treatment of breast cancer using blue dye, radioisotope, and indocyanine greeocally advanced breast cancer patientsLocally advanced breast cancer patientssentinel lymphnodesSentinel lymph node biopsyindocyanine greenneoadjuvant chemotherapyTCTR20200730003Department of surgery Faculty of medicine Ramathibodi Hospital , Mahidol university , Bangkok , Thai21
Not yet recruiting
Not Applicable
Sentinel lymph node detection in patients with stage Ib-III melanoma using MultiSpectral Optoacoustic Tomotraphy (MSOT) and IndoCyanine Green (ICG)Melanomaskin cancer10027476NL-OMON50265niversitair Medisch Centrum Groningen10