Clinical trial · Interventional
Hysteroscopic Lymphatic Mapping for Endometrial Cancer
Hysteroscopic Injection of Tracers for Sentinel Node Identification in Women With Endometrial Cancer
NCT00671606CI-TRIAL-00022404terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual.
Summary
Brief summary (as posted)
The goal of this clinical research study is to learn if a procedure called intraoperative (during surgery) lymphatic mapping can be used to find the sentinel lymph node in patients with endometrial cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoperative Lymphatic Mapping | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intraoperative Lymphatic Mapping
- description
- Intraoperative sentinel lymph node identification (lymphatic mapping)
- interventionNames
- Procedure: Intraoperative Lymphatic Mapping
Primary outcomes (1)
- measure
- Sentinel Node Identification Rate
- timeFrame
- 15-20 minute procedure prior to/during routine surgery for identifying the sentinel nodes
- description
- Feasibility of sentinel node identification rate using intraoperative hysteroscopic injection of patent blue dye and radiocolloid for the detection of sentinel lymph nodes in patients with endometrial cancer. Sentinel node identification before and during surgery using a gamma counter to identify lymph nodes that have absorbed Tc-99m sulfur colloid. Study feasibility assessed with enrollment of 20 participants, approximately 1 year.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: 1. Patients with biopsy confirmed endometrial cancer who have been dispositioned to undergo total hysterectomy, bilateral salpingooophorectomy and lymph node staging. 2. Surgical procedures may be performed by either laparotomy or laparoscopy. 3. If computed tomography, magnetic resonance imaging, lymphangiography, or ultrasound has been performed for preoperative assessment, there must be no evidence of metastases. Imaging is not mandatory. 4. Patients who have signed an approved informed consent and authorization permitting release of personal health information. Exclusion Criteria: 1. Patients with a preoperative diagnosis of grade I endometrioid adenocarcinoma of the uterus. 2. Patients with uterine papillary serous carcinoma. 3. Patients who have undergone endometrial ablation or a myomectomy within 1 year of the surgery for endometrial cancer. 4. Patients with known allergies to triphenylmethane compounds or technetium-99 radiocolloid. 5. Patients with a history of retroperitoneal surgery. 6. Patients with a history of pelvic radiation. 7. Patients with no lesion visible on hysteroscopy. 8. Patients with previous exposure to the tracer (to prevent risk of allergic reaction).
References
Publications (0)
Data not yet available
No reference posted for this study.