Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer

Conditions

• Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Diagnostic Imaging Testing — PROCEDURE
  Undergo imaging
• Excisional Biopsy — PROCEDURE
  Undergo sentinel lymph node excision
• Indocyanine Green Solution — DRUG
  Given via injection
• Minimally Invasive Surgery — PROCEDURE
  Undergo minimally invasive hysterectomy
• Pelvic Lymphadenectomy — PROCEDURE
  Undergo pelvic lymphadenectomy
• Questionnaire Administration — OTHER
  Ancillary studies
• Sentinel Lymph Node Mapping — PROCEDURE
  Undergo sentinel lymph node mapping

Study Details

This phase III trial compares the effect of sentinel lymph node mapping to standard lymph node dissection in reducing the risk of swelling in the legs (lymphedema) in patients undergoing a hysterectomy for stage I endometrial cancer. Standard lymph node dissection removes lymph nodes around the uterus during a hysterectomy to look for spread of cancer from the uterus to nearby lymph nodes. Sentinel lymph node mapping uses a special dye and camera to look for cancer that may have spread to nearby lymph nodes. Comparing the results of the procedures may help doctors predict the risk of long-term swelling in the legs.

Key Dates

Start date

Dec 7, 2022

Status verified

Mar 2026

Primary completion

Oct 31, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

428 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Arm 1 (sentinel lymph node mapping)
  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.
• Experimental: Arm 2 (sentinel lymph node mapping, pelvic lymphadenectomy)
  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.

Primary Outcome Measure

Incidence of patient-reported lower extremity limb dysfunction [ Time Frame: From 18 months post-hysterectomy after undergoing lymphatic assessment to 39 months ]

Locations (55)

Find similar trials in Washington D.C., DC