Clinical trial · Interventional
Lymph Node Mapping in Patients With Newly Diagnosed Endometrial Cancer Undergoing Surgery
Sentinel Lymph Node Mapping for Endometrial Cancer
NCT01939028CI-TRIAL-00046837terminatedN/AResults 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)
This clinical trial studies lymph node mapping in patients with newly diagnosed endometrial cancer undergoing surgery. Lymph node mapping may help in planning surgery to remove endometrial cancer and affected lymph nodes.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage I Endometrial Carcinoma | Endometrial Carcinoma | CURATED_BROADER | 0.78 |
| Stage II Endometrial Carcinoma | Endometrial Carcinoma | CURATED_BROADER | 0.78 |
| Stage III Endometrial Carcinoma | Endometrial Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Endometrial Carcinoma | Endometrial Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| indocyanine green solution | Drug | — | UNRESOLVED |
| isosulfan blue | Drug | — | UNRESOLVED |
| lymphadenectomy | Procedure | — | UNRESOLVED |
| lymph node mapping | Procedure | — | UNRESOLVED |
| sentinel lymph node biopsy | Procedure | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (SLN mapping, biopsy, surgery)
- description
- Patients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy.
- interventionNames
- Procedure: lymph node mapping
- Procedure: sentinel lymph node biopsy
- Drug: isosulfan blue
- Drug: indocyanine green solution
- Procedure: therapeutic conventional surgery
- Procedure: lymphadenectomy
Primary outcomes (6)
- measure
- Sensitivity of Sentential Lymph Node (SLN) Biopsy
- timeFrame
- Up to 4 weeks
- description
- Sensitivity estimated as the proportion of true positives among participants with lymph node metastases. Sensitivity Calculation= the number of patients with a positive SLN over those patients with a positive SLN plus those patients with a false negative lymph node.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Women must have newly diagnosed histologically or cytologically confirmed endometrial cancer * Women should have received no prior therapy for their disease * Women who are planning to undergo hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymphadenectomy for the management of their endometrial cancer * Women must have the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Women who are receiving any other investigational agents * Women with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to isosulfan blue or indocyanine green or other agents used in this study * Women with hypersensitivity to phenylmethane compounds, or a history of allergic reaction to iodides * Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Women with a history of prior loop electrosurgical excision procedure (LEEP) or cone procedures performed on their cervix * Women with a history of lymphedema, lymphoma, or lymphatic hyperplasia (Castleman disease) * Women with a history of a prior malignancy * Women may also be excluded at the discretion of their surgeon if he or she feels that the patient is not an appropriate candidate
References
Publications (0)
Data not yet available
No reference posted for this study.