Clinical trial NCT06697054: Sentinel Lymph Node (SLN) Mapping with Charcoal Carbon Dye in Early Stage Cervical Cancer
Official title: Use of Charcoal Carbon Dye in Sentinel Lymph Node (SLN) Mapping in Early Stage Cervical Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cervical Cancers
Keywords: cervical cancer
indocyanine green
ICG
carbon dye
sentinel lymph node
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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).

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).

Eligibility criteria: Inclusion Criteria: Early stage cervical cancer Stage IA-IB3

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Exclusion Criteria:

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

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Primary outcomes:
measure: Detection rate of sentinel lymph node(s)
timeFrame: Two years
measure: Specifity of sentinel lymph node mapping by carbon dye or ICG
timeFrame: Two years
measure: Sensitivity of both tracers will be compared.
timeFrame: Two years
measure: Sensitivity of both tracers will be compared.
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: İ̇stanbul
country: Turkey
facility: Istanbul University Med Fac Dept. of Obstet and Gynecol. Division of Gynecologic Oncology
Study officials:
affiliation: ISTANBUL UNİVERSİTY MED FAC DEPT. OF OBSTET AND GYNECOL. DIVISION OF GYNECOLOGİC ONCOLOGY
name: Yavuz Salihoglu, Prof. Dr.
role: STUDY_DIRECTOR
References:
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citation: 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.
citation: 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.
citation: 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.