Clinical trial · Interventional
Sentinel Lymph Node (SLN) Mapping with Charcoal Carbon Dye in Early Stage Cervical Cancer
Use of Charcoal Carbon Dye in Sentinel Lymph Node (SLN) Mapping in Early Stage Cervical Cancer
NCT06697054CI-TRIAL-00082773SLNactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancers | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sentinel node biopsy with either ICG or carbon dye injection to cervix | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Two different tracers as a sentinel lymph node agent will be compared in early cervical cancer
- description
- 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.
- interventionNames
- Diagnostic Test: Sentinel node biopsy with either ICG or carbon dye injection to cervix
Primary outcomes (4)
- measure
- Detection rate of sentinel lymph node(s)
- timeFrame
- Two years
- description
- Detection rate of sentinel lymph node(s) either by carbon dye or ICG unilaterally or bilaterally will be recorded and compared.
- measure
- Specifity of sentinel lymph node mapping by carbon dye or ICG
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Early stage cervical cancer Stage IA-IB3 \- Exclusion Criteria: 1.Pervious radiotherapy 2.Age less than 18 3.Previous pelvic retroperitoneal surgery \-
References
Publications (4)
- BACKGROUNDASGE 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
- BACKGROUNDSun 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
- BACKGROUNDHolloway 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
- BACKGROUNDMargioula-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