Giving 177Lu-PSMA-617 (Pluvicto) through a port (TIVAP)
Experience of PLUVICTO (PSMA-617 Labelled With Lutetium-177) Administration on Totally Implantable Venous Access Port (TIVAP)
This project tests whether giving 177Lu-PSMA-617 (Pluvicto) through a totally implantable venous access port (TIVAP) leaves measurable radioactivity in the port for patients receiving Pluvicto.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 107 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Male |
| Sponsor | Central Hospital, Nancy, France Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Vandœuvre-lès-Nancy and 1 other locations) |
| Trial ID | NCT06858995 on ClinicalTrials.gov |
What this trial studies
This observational project uses laboratory (in vitro/ex vivo) experiments followed by in vivo measurements to determine whether 177Lu-PSMA-617 adheres to or is retained by TIVAP devices during administration. The team will measure residual radioactivity on the port after routine Pluvicto infusions and correlate those findings with SPECT/CT dosimetry performed 2–4 hours after injection. Participants are patients who receive Pluvicto as part of their cancer care and have had the scheduled SPECT/CT; no changes to clinical care or additional drug administration are planned. The main outcome is the amount of residual activity on the TIVAP after standard infusion procedures.
Who should consider this trial
Good fit: Ideal candidates are men with PSMA-positive metastatic castration-resistant prostate cancer who receive Pluvicto, have a TIVAP in place, and undergo a SPECT/CT 2–4 hours after injection.
Not a fit: Patients without a TIVAP, those who do not undergo the required 2–4 hour SPECT/CT, or those who decline data use are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, this could support safely using existing port systems for Pluvicto administration and reduce the need for repeated peripheral IV sticks in elderly oncology patients.
How similar studies have performed: Using TIVAPs for Pluvicto is largely untested and regulatory guidance currently favors standard intravenous catheters, so comparable published data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with an injection of Pluvicto as part of the treatment of their prostate cancer, having had a SPECT/CT scan for dosimetry within 2 to 4 hours after injection. Exclusion Criteria: * Patients who have refused to have their data used for research purposes
Where this trial is running
Vandœuvre-lès-Nancy and 1 other locations
- CHRU de NANCY — Vandœuvre-lès-Nancy, France (Recruiting)
- Nuclear medicine Department CHRU de NANCY — Vandœuvre-lès-Nancy, France (Recruiting)
Study contacts
- Study coordinator: Caroline BOURSIER, MD
- Email: c.boursier@chru-nancy.fr
- Phone: (0)383154039
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.