Charcoal Carbon Black Dye Use in Sentinel Lymph Node Mapping in Early Stage Vulvar Cancer (IFLND)

November 16, 2024 updated by: Mustafa Albayrak, Istanbul University
The aim of this study is to investigate the detection rate, sensitivity and specifity of charcoal carbon black dye as a sentinel lymph node tracer in inguinofemoral lymph node(s) in early stage vulvar cancer

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Vulvar cancer is a rare malignancy constituting approximately only 4% of all gynaecological malignancies. Treatment depends on histopathology and stage with surgery being the primary treatment modality in early stages with or without adjuvant radiotherapy depending on tumor margin status and involvement of inguinofemoral lymph nodes. Bilateral or unilateral surgical evaluation of inguinofemoral lymph nodal basin is an important part of the surgical procedure in early stage disease besides vulvar surgery since metastatic involvement dramatically changes stage, adjuvant treatment and surveillance. The usual method for surgical evaluation of inguinofemoral lymph nodes is full inguinofemoral lymph node dissection (IFLND). However, IFLND is highly related to complications such as lymphedema, incisional detachment, lymphocyst formation, lymphangitis, vessel injury and deep venous thrombosis. Over the last 10-15 years sentinel lymph node biopsy of inguinofemoral lymph nodes became a well-accepted form of surgical evaluation procedure instead of IFLND.

The present guidelines offer sentinel lymph node biopsy using various tracers and dyes used alone or in combination (either a blue dye or indocyanine green -ICG (indocyanine green) - is offered in addition to radiocolloid tracer). However, radiocolloid and ICG tracers requires expensive equipment and cumbersome procedures. On the contrary, sterile charcoal carbon dye is inexpensive and does not necessitate any further equipment to be detected. It is actually used to mark the point of resection of colon during colorectal surgery by general surgeons which is injected to the colonic mucosa preoperatively by colonoscopy.

The aim of the present study is to investigate the sensitivity, specificity, negative predictive value and positive predictive value of using charcoal carbon dye as a sentinel tracer in IFLN basin. Early-stage primary vulvar tumors less than 4 cm with any histology but without any clinically or radiographically detectable inguinofemoral lymph nodes will be included into study. Peritumoral four quadrant injections of carbon dye each 0.5 cc or two injections of 3 and 9 o'clock each 1 cc will be given. Following a 20 min interval inguinofemoral area will be dissected and full lymphadenectomy will be performed irrespective of sentinel lymph node recovery since bilateral or unilateral full inguinofemoral lymph node dissection is done in the department of the study so far. Detection rate and other parameters (sensitivity, specificity and etc.) will be compared to results of pathologic evaluation of full IFLND.

Investigators are currently two ongoing studies using charcoal carbon dye as a sentinel tracer to investigate its effectiveness compared to ICG (one in endometrial cancer and the other in ovarian cancer). Both studies are registered to ClinicalTrials.gov (NCT06163963 and NCT05927818). This will be the third of the study series using charcoal carbon dye as sentinel lymph node mapping method in gynecologic cancers (Forth one will be registered in ClinicalTrials.gov shortly in cervical cancers compared to ICG).

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İ̇stanbul, Turkey
        • Istanbul University Med Fac Dept. of Obstet and Gynecol. Division of Gynecologic Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: Women with primary early stage vulvar cancer (Figo stage I and II) who will be operated with vulvar and inguinofemoral dissection -

Exclusion Criteria: Women less than 18 years of age or who declines surgery

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm study using carbon dye as a sentinel lymph node agent in early vulvar cancer
Single arm study using carbon dye as a sentinel lymph node agent in early vulvar cancer. Sterile charcoal carbon dye will be injected around vulvar tumor which will be searched in IFLND. No other arms.
Diagnostic test: sentinel lymph node biopsy using carbon dye
Sterile Charcoal carbon dye peritumoral injection will be performed around vulvar tumor and inguinofemoral lymph node dissection will be done 20 min later (unilateral or bilateral)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rate of sentinel lymph node(s)
Time Frame: Two years
Detection of sentinel lymph node for both unilateral or bilateral inguinofemoral region (in percentages). (For instance: In what percentage a unilateral or bilateral sentinel lymph node stained with carbon dye - either negative or positive - is detected?)
Two years
Sensitivity of sentinel lymph node mapping
Time Frame: Two years
Sentinel lymph nodes true positive for malignancy in percentages divided by all sentinel lymph nodes either positive or negative for malignancy which is determined by pathologic report after all full inguinofemoral lymph nodes are examined for malignancy
Two years
Specifity of sentinel lymph node mapping
Time Frame: Two years
Detection of true negative sentinel lymph nodes for malignancy divided by all sentinel lymph nodes either positive or negative for malignancy which is determined after all full inguinofemoral lymph nodes are examined pathologically
Two years
Negative and positive predictive values
Time Frame: Two years
Detection of ratio of negative and positive for malignancy with sentinel lymph nodes to negative and positive for malignancy detected by full inguinofemoral lymph node dissection respectively
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Study Director: Yavuz Salihoglu, Prof. Dr., Istanbul University Med Fac Dept. of Obstet and Gynecol. Division of Gynecologic Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

November 15, 2024

First Submitted That Met QC Criteria

November 16, 2024

First Posted (Estimated)

November 19, 2024

Study Record Updates

Last Update Posted (Estimated)

November 19, 2024

Last Update Submitted That Met QC Criteria

November 16, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/1551

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Yes

IPD Sharing Time Frame

Data will be available in two years and will be in available forever.

IPD Sharing Access Criteria

All data set and results will be planned to open, no criteria.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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