Clinical trial · Interventional
Feasibility of Gallium-68-tilmanocept PET/CT for Sentinel Lymph Node Detection in Endometrial Cancer
SENtinel Lymph Node Mapping With GAllium-68-tilmanocept PET/CT in High/High-intermediate Risk Endometrial Cancer: a Pilot Study
NCT05446324CI-TRIAL-00071882SENGAunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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 pilot study evaluates the feasibility of 68Ga-tilmanocept PET/CT for SLN mapping 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 |
|---|---|---|---|
| Gallium-68-tilmanocept | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-tilmanocept PET/CT
- description
- All participants receive 68Ga-tilmanocept PET/CT imaging in adjunct to standard-of-care (SLN mapping with intraoperative ICG).
- interventionNames
- Drug: Gallium-68-tilmanocept
Primary outcomes (1)
- measure
- Feasibility of 68Ga-tilmanocept PET/CT for SLN mapping
- timeFrame
- One week post-PET/CT
- description
- Assessed by the SLN detection rate with 68Ga-tilmanocept PET/CT. Overall SLN detection rate is defined as the proportion of patients in which at least one SLN is detected. Bilateral SLN detection rate is defined as the proportion of patients with at least one SLN detected in each hemipelvis or para-aortic side.
Secondary outcomes (3)
- measure
- Correlation between SLN detection rate and anatomical location with preoperative 68Ga-tilmanocept PET/CT versus intraoperative ICG with near-infrared fluorescence.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical FIGO 2012 stage I-II high/high-intermediate risk endometrial cancer; * Scheduled for robot-assisted full pelvic and para-aortic staging; * Age ≥18 years and able to provide informed consent. Exclusion Criteria: * Pregnancy or current breastfeeding; * Prior severe allergic reaction to iodine; * Severe renal insufficiency (stage 3 or 4); * Clinical or radiological evidence of metastatic disease.
References
Publications (0)
Data not yet available
No reference posted for this study.