Sentinel Lymph Node (SLN) Mapping with Charcoal Carbon Dye in Early Stage Cervical Cancer (SLN)

November 17, 2024 updated by: Mustafa Albayrak, Istanbul University

Use of Charcoal Carbon Dye in Sentinel Lymph Node (SLN) Mapping in Early Stage Cervical Cancer

The aim of the present study is to compare the efficacy of charcoal carbon dye (CCD) in sentinel lymph node mapping compared to indocyanine green (ICG) mapping regarding detection rates, sensitivity, specificity, negative and positive predictive values in early stage cervical cancers (IA2 - IB2).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Cervical cancer continues to be a global health problem despite the advances in prevention, screening and treatment in preinvasive stages. Although radiotherapy is the mainstay of treatment across all stages, surgery with radical and non-radical hysterectomy with pelvic lymph node evaluation is preferred in younger women with early stage cervical cancer who wants to preserve ovarian and sexual functions that may otherwise be hampered by radiotherapy. Lymph node evaluation is critical during and/or after surgery (usually before hysterectomy) and offered by global institutions since hysterectomy during surgery is abandoned in case of a metastasis in pelvic / paraaortic lymph node(s) and/or necessities primary chemoradiation or adjuvant therapy as a therapeutic modality.

During the last 10-15 years surgical sentinel lymph node (SLN) evaluation instead of complete dissection pelvic / paraaortic lymphadenectomy has gained popularity with equal success, especially in cervical tumors with less than 2-4 cm in diameter. Besides, all other advantages of sentinel lymph node evaluation is alike the advantages of other sentinel lymph node evaluation in various other cancers (vulva, breast, endometrial cancers..) with less morbidity such as less vascular injury, lymphedema, lymphocyst formation and etc. Various tracers have been used for sentinel lymph node detection in cervical cancer surgery but indocyanine green (ICG) use has surpassed other SLN mapping tracers and methods and it is the most common agent for detecting SLN in gynecologic oncology. However, it needs a fairly expensive equipment and expertise either by laparoscopy or laparotomy. In the present study, investigators are planning to use charcoal carbon dye (CCD) in addition to ICG as their usual method for SLN mapping. CCD is commonly used by general surgeons for marking of colon during preoperative colonoscopy to delineate the point of resection in surgery for colorectal resection. It is cheap and does not require special equipment and easy to learn. CCD is planned to be given just as the same as giving ICG to the cervix with 1 cc injection at each site of external os (3 and 9 o'clock position, 0.5 cc given to submucosal area and 0.5 given stroma of cervix). 20 minutes following the injection of both agents, laparoscopic dissection of retroperitoneal area will be performed to detect pelvic and paraaortic sentinel lymph nodes (up to inferior mesenteric artery) with ICG and/or CCD.

The aim of the present study is to compare the efficacy of CCD in sentinel lymph node mapping compared to ICG mapping regarding detection rates, sensitivity, specificity, negative and positive predictive values in early stage cervical cancers (IA2 - IB2).

Study Type

Interventional

Enrollment (Estimated)

60

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: Early stage cervical cancer Stage IA-IB3

-

Exclusion Criteria:

1.Pervious radiotherapy 2.Age less than 18 3.Previous pelvic retroperitoneal 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: Two different tracers as a sentinel lymph node agent will be compared in early cervical cancer
Two different tracers, one charcoal carbon dye and other indocyanine used as sentinel lymph node agent will be compared in early cervical cancer in terms of detection rates, sensitivity, specificity, negative and positive predictive value. Both tracers will be used in the patient.
Diagnostic test: Sentinel node biopsy with either ICG or carbon dye injection to cervix
Either laparatomy or laparoscopy wil be performed to detect sentinel node stained with either ICG or carbon dye injected to cervix. A hemipelvis in which a sentinel is not found will be subjected to full lymphadenectomy.

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 rate of sentinel lymph node(s) either by carbon dye or ICG unilaterally or bilaterally will be recorded and compared.
Two years
Specifity of sentinel lymph node mapping by carbon dye or ICG
Time Frame: Two years
Sensitivities of both tracers for malignancy will be compared to each other
Two years
Sensitivity of both tracers will be compared.
Time Frame: Two years
Sensitivity of both tracers will be compared for malignant metastasis
Two years
Sensitivity of both tracers will be compared.
Time Frame: Two years
Positive and negative predictive values of both tracers for malignant metastasis will be compared.
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 12, 2024

Primary Completion (Estimated)

May 12, 2026

Study Completion (Estimated)

June 12, 2026

Study Registration Dates

First Submitted

November 17, 2024

First Submitted That Met QC Criteria

November 17, 2024

First Posted (Estimated)

November 20, 2024

Study Record Updates

Last Update Posted (Estimated)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 17, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/1550

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data will be shared except personal privacy related ones

IPD Sharing Time Frame

two years

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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