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Sentinel Lymph Node Mapping for Endometrial Cancer

New Orleans, LA

Phase 3

Recruiting

Led By Edward Tanner, MD

Research Sponsored by NRG Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment and at 3, 6, 9, 12, and 18 months after surgery

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares sentinel lymph node mapping vs. standard lymph node dissection to reduce risk of leg swelling in patients undergoing hysterectomy for stage I endometrial cancer.

Who is the study for?

This trial is for adults with stage I endometrial cancer who are planning a hysterectomy and lymphatic assessment. They must be in good general health, not have chronic leg swelling or recent infections, radiation, or surgery that could affect the legs or pelvis. Prior cancers are okay if they don't impact this study's safety.

What is being tested?

The trial compares sentinel lymph node mapping (using dye and camera to find cancer spread) to standard lymph node dissection during hysterectomy in reducing leg swelling risk. It aims to determine which method better predicts long-term limb dysfunction.

What are the potential side effects?

Potential side effects may include reactions to indocyanine green solution used for mapping, complications from minimally invasive surgery such as infection or bleeding, and discomfort from questionnaire administration.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment and at 3, 6, 9, 12, and 18 months after surgery.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment and at 3, 6, 9, 12, and 18 months after surgery.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment and at 3, 6, 9, 12, and 18 months after surgery. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of patient-reported lower extremity limb dysfunction

Secondary study objectives

Rate of perioperative complications

Rate of successful bilateral SLN identification

Rate of successful identification of lymph node metastasis

+2 more

Other study objectives

Adjuvant therapy decisions

Overall survival

Progression free survival

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2 (sentinel lymph node mapping, pelvic lymphadenectomy)Experimental Treatment8 Interventions

Patients receive ICG dye via injection and undergo sentinel lymph node mapping and excision during standard minimally invasive hysterectomy. Additional lymph nodes around the uterus are removed per standard of care. Patients also undergo imaging as clinically indicated and optional blood sample collection throughout the study.

Group II: Arm 1 (sentinel lymph node mapping)Experimental Treatment8 Interventions

Patients receive ICG dye via injection and undergo sentinel lymph node mapping and excision during standard minimally invasive hysterectomy. Lymph nodes around the uterus may be removed if the mapping and excision cannot be completed. Successful mapping requires no additional removal of lymph nodes. Patients also undergo imaging as clinically indicated and optional blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~1810

Excisional Biopsy

2017

N/A

~50