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Study of sentinel lymph node biopsy in early ovarian cancer

Evaluation Of Sentinel Node Biopsy In Early Epithelial Ovarian Cancer Using Methylene Blue And Fluorescein Dye In A Tertiary Care Centre Of North East India

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/07/044474
Enrollment
20
Registered
2022-07-29
Start date
Unknown
Completion date
Unknown
Last updated
2022-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: X- New Technology

Interventions

Intervention1: Nil: Nil Intervention2: SENTINEL NODE BIOPSY IN EARLY EPTHELIAL OVARIAN CANCER USING METHYLENE BLUE AND FLUORESCEIN DYE: A NOVEL APPROACH OF USING FLUORESCEIN DYE IN THIS SETTING AND F

Sponsors

APOORVA TAK
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1. Age 18 and above. 2. Patients with a high likelihood of having a malignant ovarian tumor planned for exploratory laparotomy 3. Patients referred with confirmed ovarian tumor after previous surgery ( unilateral or bilateral salpingo-oophrectomy with or without hysterectomy) , those in whom the ovarian malignant tumour has already been resected and a second surgical procedure is planned to complete the staging procedure including lymph nodes.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1. Previous vascular surgery of aorta,caval vein or iliac vessels 2. Previous lymphadenectomy or lymph node sampling in the iliac or paraortic region 3. History of malignant lymphoma 4. History of malignant tumor in abdominal cavity • Previous allergic reaction to blue dye or human albumin • Pregnant or lactating females

Design outcomes

Primary

MeasureTime frame
primary end objective is to report any adverse event related to the technique, as well as the feasibility of the techniqueTimepoint: 1-month ( 4 weeks) post procedure

Secondary

MeasureTime frame
The second exploratory objectives are to report sensitivity, specificity, and the positive and negative predictive values of the technique, the detection rate and location of sentinel lymph nodesTimepoint: 4 weeks post procedure

Countries

India

Contacts

Public ContactAPOORVA TAK

Dr Bhubaneshwar Borooah Cancer Institute

drdbarmon@gmail.com6378762076

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 8, 2026