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

NCT06858995 | Completed

• 1 other identifier: 2025PI037
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 2

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.

Conditions

Administration of Therapy

Outcome Measures

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

  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

  1 day

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients who have refused to have their data used for research purposes

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (2)

CHRU de NANCY

Vandœuvre-lès-Nancy, 54511, France

Location

Nuclear medicine Department CHRU de NANCY

Vandœuvre-lès-Nancy, 54511, France

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 5, 2025
• Study Start: June 5, 2025
• Primary Completion: June 19, 2025
• Study Completion: July 30, 2025
• Last Updated: June 4, 2026

Record last verified: 2026-06

Locations

FR (2)