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

NCT06697054Active, Not RecruitingNAINTERVENTIONAL

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).

Key Facts

Lead Sponsor

Istanbul University

Enrollment

Start Date

2024-05-12

Completion Date

2026-05-12

Study Type

INTERVENTIONAL

Official Title

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

Interventions

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

Conditions

Cervical Cancers

Eligibility

Age Range

18 Years+

Sex

FEMALE

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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Outcome Measures

Primary Outcomes

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.

Time frame: 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

Time frame: Two years

Sensitivity of both tracers will be compared.

Sensitivity of both tracers will be compared for malignant metastasis

Time frame: Two years

Sensitivity of both tracers will be compared.

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

Time frame: Two years

Locations

Istanbul University Med Fac Dept. of Obstet and Gynecol. Division of Gynecologic Oncology, Istanbul, Turkey (Türkiye)

Linked Papers

Feasibility of Sentinel Lymph Node Mapping With Carbon Nanoparticles in Cervical Cancer: A Retrospective Study

Introduction This retrospective study aims to investigate the feasibility of using carbon nanoparticles to detect sentinel lymph nodes (SLNs) in cervical cancer. Methods This study involved 174 patients with cervical cancer. Cervix tissues adjacent to the cancer were injected with 1 mL of carbon nanoparticles (CNPs) at the 3 and 9 o’clock positions according to the instructions. The pelvic lymph nodes were then dissected, and the black-stained sentinel lymph nodes were sectioned for pathological examination. Results Of 174 cases, 88.5% of patients (154/174) had at least 1 sentinel lymph node, and 131 patients (75.29%) had bilateral pelvic sentinel lymph nodes. The left pelvic lymph node was the most common sentinel lymph node (34.16%). At least 1 sentinel lymph node was observed in 285 out of 348 hemipelvises, with a detection rate of a side-specific sentinel lymph node of 81.89%. In total, 47 hemipelvises had metastasis of the lymph node, and 33 involved the sentinel lymph node, with a sensitivity of 70.21% and a false-negative rate of 29.79%. There were 238 hemipelvises with no metastasis of the lymph node, as well as negative sentinel lymph nodes, with a specificity of 100% and a negative predictive value of 94.44%. The univariate analysis demonstrated that risk factors included tumor size (OR .598, 95% CI: .369-.970) and deep stromal invasion (OR .381, 95% CI: .187-.779). The deep stromal invasion was the only variable for the false-negative detection of a sentinel lymph node. Conclusion Sentinel lymph node mapping with carbon nanoparticles might be applied to predict the metastasis of pelvic lymph nodes in cervical cancer. However, tumor size and deep stromal invasion might negative influence the detection rate of SLN.

Linked Investigators

Xing Chen