Clinical trial · Interventional
PET/CT and Lymph Node Mapping in Finding Lymph Node Metastasis in Patients With High-Risk Endometrial Cancer
Prospective Evaluation of Lymph Node Metastasis at the Time of Surgical Staging for High Risk Endometrial Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This clinical trial studies positron emission tomography (PET)/computed tomography (CT) and lymph node mapping in finding lymph node metastasis in patients with endometrial cancer that is at high risk of spreading. A PET/CT scan is a procedure that combines the pictures from a PET scan and a CT scan, which are taken at the same time from the same machine. The combined scans give more detailed pictures of areas inside the body than either scan gives by itself. Lymph node mapping uses a radioactive dye, called indocyanine green solution, to identify lymph nodes that may contain cancer cells. PET/CT and sentinel lymph node mapping may be better ways than surgery to identify cancer in the lymph nodes.
Conditions
Conditions (5)
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 Clear Cell Adenocarcinoma | Endometrial Clear Cell Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Endometrial Mixed Adenocarcinoma | — | UNRESOLVED | — |
| Endometrial Serous Adenocarcinoma | Endometrial Serous Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Grade 3 Endometrial Endometrioid Adenocarcinoma | — | UNRESOLVED | — |
| Malignant Mixed Mesodermal (Mullerian) Tumor | Malignant Mixed Mesodermal (Mullerian) Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography | Procedure | — | UNRESOLVED |
| Indocyanine Green Solution | Drug | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Lymphadenectomy | Procedure | — | UNRESOLVED |
| Lymph Node Mapping | Procedure | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (PET/CT, lymph node mapping)
- description
- Patients undergo PET/CT prior to surgery. Patients then undergo intraoperative lymph node mapping with indocyanine green solution, given via superficial and deep cervical injection during full lymphadenectomy.
- interventionNames
- Procedure: Computed Tomography
- Drug: Indocyanine Green Solution
- Other: Laboratory Biomarker Analysis
- Procedure: Lymph Node Mapping
- Procedure: Lymphadenectomy
- Procedure: Positron Emission Tomography
Primary outcomes (1)
- measure
- False Negative Rate of PET/CT Verses Sentinel Lymph Node Mapping in the Detection of Positive Lymph Nodes in Women With High Risk Endometrial Cancers.
- timeFrame
- 36 months
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed high grade endometrial cancer including grade 3 endometroid, serous, clear cell, malignant mixed Mullerian tumor (MMMT) or any mixed tumor containing one of these cell types * Patients with a grade 1/2 tumors and evidence of deep myometrial invasion or cervical involvement on preoperative imaging or physical exam * Candidate for surgery * No evidence of peritoneal disease on preoperative imaging * Negative pregnancy test if of child-bearing age * No preoperative treatment for endometrial cancer including radiation or chemotherapy * Previous hormonal therapy is allowed Exclusion Criteria: * Medical co-morbidities making surgery unsafe, as determined by the primary treating physician * Any contraindications to PET/CT or lymph node mapping (inability to control serum glucose to a value of =\< 200 mg/dl for fludeoxyglucose F-18 \[FDG\]-PET/CT) * Does not meet histologic criteria * Evidence of peritoneal or distant metastasis on preoperative imaging * Baseline creatinine (necessary for imaging studies)
References
Publications (0)
Data not yet available