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Completed

NCT Number: NCT06858995

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

Male

Study type

Observational

Primary location

CHRU de NANCY, Vandœuvre-lès-Nancy, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

to measure the residual activity on the Totally Implantable Venous Access Port

Other

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.

Primary outcomes

  1. Show that the residual activity at the port reservoir level is negligible, there is no 177Lu-PSMA-617 accumulation at the port reservoir level above the blood background noise

    Time frame: 1 day

    The 4 ml regions of interest (VOI = volume of interest) were manually drawn on the PAC on each SPECT/CT. The blood background was determined by a VOI drawn on the right atrium

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: PLUVIPAC

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 5, 2025
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.