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

NCT06697054 | Active Not Recruiting DMC

• 1 other identifier: 2024/1550
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cervical Cancers

Keywords

cervical cancer; indocyanine green; ICG; carbon dye; sentinel lymph node

Outcome Measures

Primary Outcomes (4)

• Detection rate of sentinel lymph node(s)

  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

  Sensitivities of both tracers for malignancy will be compared to each other

  Two years

• Sensitivity of both tracers will be compared.

  Sensitivity of both tracers will be compared for malignant metastasis

  Two years

• Sensitivity of both tracers will be compared.

  Positive and negative predictive values of both tracers for malignant metastasis will be compared.

  Two years

Study Arms (1)

Two different tracers as a sentinel lymph node agent will be compared in early cervical cancer

EXPERIMENTAL

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

Interventions

Sentinel node biopsy with either ICG or carbon dye injection to cervix DIAGNOSTIC_TEST

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.

Two different tracers as a sentinel lymph node agent will be compared in early cervical cancer

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female (cervical cancer)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Pervious radiotherapy 2.Age less than 18 3.Previous pelvic retroperitoneal surgery

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Med Fac Dept. of Obstet and Gynecol. Division of Gynecologic Oncology

Istanbul, Turkey, Turkey (Türkiye)

Location

Related Publications (4)

• ASGE Technology Committee; Kethu SR, Banerjee S, Desilets D, Diehl DL, Farraye FA, Kaul V, Kwon RS, Mamula P, Pedrosa MC, Rodriguez SA, Wong Kee Song LM, Tierney WM. Endoscopic tattooing. Gastrointest Endosc. 2010 Oct;72(4):681-5. doi: 10.1016/j.gie.2010.06.020.

  PMID: 20883844 BACKGROUND

• Sun W, Chen X, Fu S, Huang X. Feasibility of Sentinel Lymph Node Mapping With Carbon Nanoparticles in Cervical Cancer: A Retrospective Study. Cancer Control. 2023 Jan-Dec;30:10732748231195716. doi: 10.1177/10732748231195716.

  PMID: 37624147 BACKGROUND

• Holloway RW, Abu-Rustum NR, Backes FJ, Boggess JF, Gotlieb WH, Jeffrey Lowery W, Rossi EC, Tanner EJ, Wolsky RJ. Sentinel lymph node mapping and staging in endometrial cancer: A Society of Gynecologic Oncology literature review with consensus recommendations. Gynecol Oncol. 2017 Aug;146(2):405-415. doi: 10.1016/j.ygyno.2017.05.027. Epub 2017 May 28.

  PMID: 28566221 BACKGROUND

• Margioula-Siarkou C, Almperis A, Gullo G, Almperi EA, Margioula-Siarkou G, Nixarlidou E, Mponiou K, Papakotoulas P, Sardeli C, Guyon F, Dinas K, Petousis S. Sentinel Lymph Node Staging in Early-Stage Cervical Cancer: A Comprehensive Review. J Clin Med. 2023 Dec 20;13(1):27. doi: 10.3390/jcm13010027.

  PMID: 38202034 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Study Officials

• Yavuz Salihoglu, Prof. Dr.

  ISTANBUL UNİVERSİTY MED FAC DEPT. OF OBSTET AND GYNECOL. DIVISION OF GYNECOLOGİC ONCOLOGY

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A single arm interventional study aiming at the comparison of the effectiveness of detection for sentinel lymph node biopsy using charcoal carbon dye compared to classic indocyanine (ICG) tracer in early stage cervical cancer. Sentinel lymph node detection rates of both tracers in pelvic, obturator and inframesenteric para-aortic whteher bilateral/ unilateral) will be compared in addition to sensitivity, specificity and negative and positive predictive value.

Study Record Dates

• First Submitted: November 17, 2024
• First Posted: November 20, 2024
• Study Start: May 12, 2024
• Primary Completion: May 12, 2026
• Study Completion: June 12, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: two years

Locations

TU (1)