Clinical trial NCT06858995: Experience of 177Lu-PSMA-617-administration on Port Reservoir (TIVAP)
Official title: Experience of PLUVICTO (PSMA-617 Labelled With Lutetium-177) Administration on Totally Implantable Venous Access Port (TIVAP)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Administration Into a Totally Implantable Venous Access Port for Radiatherapy Internal Vectorized
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 107
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients following 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 over the period from February 2022 to October 2023 are concerned by this study.

Brief 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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre les Nancy cedex
country: France
facility: CHRU de NANCY
city: Vandoeuvre les Nancy cedex
country: France
facility: Nuclear medicine Department CHRU de NANCY
Study officials:
References: