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Checking the practicality and safety to identify lymphnodes in patients undergoing surgery for early uterine cancer using special dye and hand held camera- A study from tertiary center

Feasibility, sensitivity and detection rate of Sentinel Lymph Node Mapping Using hand-held NIR Fluorescence camera with ICG in Early Stage Endometrial Cancer: A pilot study from a tertiary cancer care Center. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/081497
Enrollment
20
Registered
2025-03-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: C541- Malignant neoplasm of endometrium Health Condition 2: N858- Other specified noninflammatory disorders of uterus

Interventions

Intervention1: Uterine Cervical injection of Indocyanine green dye: All cases of early endometrial cancer cases undergoing laparotomy for staging surgery Uterine Cervical injection of Indocyanine gree

Sponsors

Dr Amy Jose Primary Investigator
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Biopsy confirmed endometrial carcinoma patients with any histology and grade 2. Clinical and radiological (CT/MRI abdomen and pelvis or whole body PET Ct) early stage endometrial carcinoma undergoing staging laparotomy 3. Willingness to be part of the trial

Exclusion criteria

Exclusion criteria: Extra uterine disease or those who received neoadjuvant radiation/ chemotherapy for the present disease or those with previous h/o pelvic irradiation or pelvic node dissection for any cause

Design outcomes

Primary

MeasureTime frame
Primary 1. Evaluation o feasibility of open ICG fluorescent injection technique for SLN mapping in carcinoma endometrium 2. To detect the sensitivity and specificity, positive and negative predictive values of open SLN testing in carcinoma endometrium. Secondary Objective- To analyse the detection rate- unilateral, bilateral and sites of detectionTimepoint: Study is planned to carry out in first 20 cases of carcinoma endometrium undergoing laparotomy surgery. All outcomes are measured at single point, during surgery and at the final pathological confirmation Day 0, 3 weeks post surgery—

Secondary

MeasureTime frame
Secondary Objective- To analyse the detection rate- unilateral, bilateral & sites of detectionTimepoint: Study is planned to carry out in first 20 cases of carcinoma endometrium undergoing laparotomy surgery. All outcomes are measured at single point, during surgery & at the final pathological confirmation. Day 0 & at 3 weeks post surgery—

Countries

India

Contacts

Public ContactAmy Jose

Cancer Institute(WIA) Adyar

JOSE.AMY@GMAIL.COM9445586032

Outcome results

None listed

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