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

NCT06694116 | Active Not Recruiting DMC

• 1 other identifier: 2024/1551
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vulval Cancer; Sentinel Lymph Node Detection

Keywords

vulvar cancer; observatinal study; charcoal carbon dye

Outcome Measures

Primary Outcomes (4)

• Detection rate of sentinel lymph node(s)

  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

  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

  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

  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

Study Arms (1)

Single arm study using carbon dye as a sentinel lymph node agent in early vulvar cancer

EXPERIMENTAL

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

Interventions

sentinel lymph node biopsy using carbon dye DIAGNOSTIC_TEST

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)

Single arm study using carbon dye as a sentinel lymph node agent in early vulvar cancer

Eligibility Criteria

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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

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

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

• 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

• 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

• Rychlik A, Bidzinski M, Rzepka J, Piatek S. Sentinel lymph node in vulvar cancer. Chin Clin Oncol. 2021 Apr;10(2):19. doi: 10.21037/cco-20-202. Epub 2020 Dec 11.

  PMID: 33353362 BACKGROUND

• Penn CA, Schneiter MK, Watson CH. Sentinel Lymph Node Evaluation in Early-Stage Vulvar Cancer. Curr Treat Options Oncol. 2024 Jan;25(1):20-26. doi: 10.1007/s11864-023-01165-1. Epub 2024 Jan 3.

  PMID: 38170388 BACKGROUND

• Pedrao PG, Guimaraes YM, Godoy LR, Possati-Resende JC, Bovo AC, Andrade CEMC, Longatto-Filho A, Dos Reis R. Management of Early-Stage Vulvar Cancer. Cancers (Basel). 2022 Aug 29;14(17):4184. doi: 10.3390/cancers14174184.

  PMID: 36077719 BACKGROUND

MeSH Terms

Conditions

Vulvar Neoplasms

Condition Hierarchy (Ancestors)

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

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: The aim of this single arm prospective observational and intervational study is to investigate the detection rate, 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. The parameters will be compared to pathologic results obtained from full IFLND.

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: May 30, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available in two years and will be in available forever.
• Access Criteria: All data set and results will be planned to open, no criteria.

Locations

TU (1)