Using Gallium-68-tilmanocept PET/CT for 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
This study is testing a new imaging method using Gallium-68-tilmanocept PET/CT to see if it can help find lymph nodes in patients with early-stage endometrial cancer better than current methods.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | UMC Utrecht Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Utrecht) |
| Trial ID | NCT05446324 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the feasibility of using Gallium-68-tilmanocept PET/CT imaging for sentinel lymph node (SLN) mapping in patients with endometrial cancer. The study aims to improve SLN detection rates by combining preoperative imaging with this radiotracer alongside the standard intraoperative technique using indocyanine green. A total of 10 patients with clinically stage I-II high/high-intermediate risk endometrial cancer will receive a cervical injection of 68Ga-tilmanocept followed by PET/CT imaging before their scheduled robot-assisted lymphatic staging procedure. The primary endpoint is the feasibility of this imaging technique as measured by SLN detection rates.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 and older with clinical stage I-II high/high-intermediate risk endometrial cancer scheduled for robot-assisted pelvic and para-aortic lymphatic staging.
Not a fit: Patients who are pregnant, breastfeeding, have severe renal insufficiency, or evidence of metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the accuracy of lymph node detection in endometrial cancer, potentially leading to better surgical outcomes.
How similar studies have performed: While the use of indocyanine green is established, the application of Gallium-68-tilmanocept PET/CT for this purpose is a novel approach that has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Utrecht
- Cornelis G Gerestein — Utrecht, Netherlands (Recruiting)
Study contacts
- Principal investigator: Cornelis G Gerestein, MD, PhD — UMC Utrecht
- Study coordinator: Cornelis G Gerestein, MD, PhD
- Email: C.G.Gerestein-2@umcutrecht.nl
- Phone: +31616770541
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.