NCT06858995

Experience of 177Lu-PSMA-617-administration on Port Reservoir (TIVAP)

Experience of PLUVICTO (PSMA-617 Labelled With Lutetium-177) Administration on Totally Implantable Venous Access Port (TIVAP)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 107 (estimated)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: Male
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

According to Pluvicto® indication, most of patients treated are elderly, with limited/poor venous peripheric access but they received previously chemotherapy through TIVAP and TIVAP generally stays in the body of patients when they are referred for Pluvicto® therapy. This is why TIVAP could be an interesting alternative for administering of 177Lu-PSMA-617. The aim of this study is to assess potential retention of 177Lu-PSMA-617 on TIVAP during administration through in vitro/ex vivo experimentations then in in vivo analysis.

Detailed description

Pluvicto® (177Lu-PSMA-617) was approved in the USA by the Food and Drug Administration (FDA) in March 2022 and in Europe in December 2022 for the treatment of adult patients with progressive, prostate-specific membrane antigen (PSMA)-positive, castration-resistant, metastatic prostate cancer (mCRPC) who have been treated with androgen pathway-inhibiting hormone therapy and taxane-based chemotherapy. The European Medicines Agency (EMA) and FDA recommends using an intravenous catheter exclusively for Pluvicto® administration, which implies that Pluvicto® administration has not to be administreted into a Totally Implantable Venous Access Port (TIVAP). In fact, administration through central venous access is preferred for repeated venous infusion in particular in oncology patients for preventing damage veins, and painful and TIVAPs is particular used for intensive and long-term chemotherapy in most oncology departments. However, according to Pluvicto® indication, most of patients treated are elderly, with limited/poor venous peripheric access but they received previously chemotherapy through TIVAP and TIVAP generally stays in the body of patients when they are referred for Pluvicto® therapy. This is why TIVAP could be an interesting alternative for administering of 177Lu-PSMA-617. The aim of this study is to assess potential retention of 177Lu-PSMA-617 on TIVAP during administration through in vitro/ex vivo experimentations then in in vivo analysis.

Conditions

• Administration of Therapy

Interventions

Type	Name	Description
OTHER	to measure the residual activity on the Totally Implantable Venous Access Port	VOI (volume of interest)TIVAP at 4 ml were drawn manually on the chamber of the TIVAP on each tomography. Blood background was determined by an VOI (volume of intesrest of Right Auricle on the right atrium. The VOIRA was automatically delineated on the CT by XXX. Standardized Uptake Value (SUV)max, SUVpeak, SUVmean were extracted from the VOIs and unilateral comparisons of superiority were performed using Wilcoxon tests. A qualitative analysis along the (TIVAP) catheter was performed: positive if an uptake was superior to the blood background and negative if any.

Timeline

• Start date: 2025-06-05
• Primary completion: 2025-06-19
• Completion: 2025-07-30
• First posted: 2025-03-05
• Last updated: 2025-06-26

Locations

2 sites across 1 country: France