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Role of Sentinel Lymph Node in Early Stage Ovarian Cancer

Evaluation of the Role of Sentinel Lymph Node Biopsy in Early Stage Ovarian Cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/06/043275
Enrollment
20
Registered
2022-06-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Health Condition 1: C569- Malignant neoplasm of unspecifiedovary Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Sentinel node detection: Patients will receive injection of tracer (Tc99m Sulphur colloid 37mBq 1mL and methylene blue dye 1% 2mL) in the ovarian and infundibulopelvic ligaments ligamen

Sponsors

AIIMS Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with stage I and II epithelial ovarian cancers Patients with suspicious ovarian masses planned for hysterectomy and or salpingo-oophorectomy

Exclusion criteria

Exclusion criteria: Signs of malignant spread to the abdominal cavity on pre-operative imaging Patients with allergies to the tracers Diagnosed with malignancy other than ovarian cancer Prior history of pelvic or para-aortic lymphadenectomy or lymph node sampling Suspicious lymph nodal involvement on imaging Pregnant or lactating patients Not willing to participate in the study

Design outcomes

Primary

MeasureTime frame
Sentinel lymph node detection rate, False negative rate and accuracy of sentinel node biopsyTimepoint: 18 months

Secondary

MeasureTime frame
Adverse events related with sentinel lymph node procedure (CTCAE version 5.0) and complete lymphadenectomyTimepoint: 18 months;Comparison of detection rate between the two tracers and in combinationTimepoint: 18 months;Identifying various sites of sentinel node locationTimepoint: 18 months

Countries

India

Contacts

Public ContactAyush Heda

AIIMS Rishikesh

rajaram.shalini@gmail.com9810704434

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026