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

NCT ID: NCT06694116

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-30
• Study Completion Date: 2026-11-30

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

Detailed Description

Vulvar cancer is a rare malignancy constituting approximately only 4% of all gynaecological malignancies. Treatment depends on histopathology and stage with surgery being the primary treatment modality in early stages with or without adjuvant radiotherapy depending on tumor margin status and involvement of inguinofemoral lymph nodes. Bilateral or unilateral surgical evaluation of inguinofemoral lymph nodal basin is an important part of the surgical procedure in early stage disease besides vulvar surgery since metastatic involvement dramatically changes stage, adjuvant treatment and surveillance. The usual method for surgical evaluation of inguinofemoral lymph nodes is full inguinofemoral lymph node dissection (IFLND). However, IFLND is highly related to complications such as lymphedema, incisional detachment, lymphocyst formation, lymphangitis, vessel injury and deep venous thrombosis. Over the last 10-15 years sentinel lymph node biopsy of inguinofemoral lymph nodes became a well-accepted form of surgical evaluation procedure instead of IFLND.

The present guidelines offer sentinel lymph node biopsy using various tracers and dyes used alone or in combination (either a blue dye or indocyanine green -ICG (indocyanine green) - is offered in addition to radiocolloid tracer). However, radiocolloid and ICG tracers requires expensive equipment and cumbersome procedures. On the contrary, sterile charcoal carbon dye is inexpensive and does not necessitate any further equipment to be detected. It is actually used to mark the point of resection of colon during colorectal surgery by general surgeons which is injected to the colonic mucosa preoperatively by colonoscopy.

The aim of the present study is to investigate the 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 into study. Peritumoral four quadrant injections of carbon dye each 0.5 cc or two injections of 3 and 9 o'clock each 1 cc will be given. Following a 20 min interval inguinofemoral area will be dissected and full lymphadenectomy will be performed irrespective of sentinel lymph node recovery since bilateral or unilateral full inguinofemoral lymph node dissection is done in the department of the study so far. Detection rate and other parameters (sensitivity, specificity and etc.) will be compared to results of pathologic evaluation of full IFLND.

Investigators are currently two ongoing studies using charcoal carbon dye as a sentinel tracer to investigate its effectiveness compared to ICG (one in endometrial cancer and the other in ovarian cancer). Both studies are registered to ClinicalTrials.gov (NCT06163963 and NCT05927818). This will be the third of the study series using charcoal carbon dye as sentinel lymph node mapping method in gynecologic cancers (Forth one will be registered in ClinicalTrials.gov shortly in cervical cancers compared to ICG).

Conditions

Vulval Cancer; Sentinel Lymph Node Detection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

sentinel lymph node biopsy using carbon dye

Intervention Type: 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)

Interventions

sentinel lymph node biopsy using carbon dye

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)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Mustafa Albayrak

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yavuz Salihoglu, Prof. Dr.

Role: STUDY_DIRECTOR

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

Locations

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

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 33353362 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38170388 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36077719 (View on PubMed)

Other Identifiers

2024/1551

Identifier Type: -

Identifier Source: org_study_id