NCT06783088

Brief Summary

The main of this study is to demonstrate the feasibility of carrying out quantitative acquisitions regardless of the energy peak considered (113 keV (kiloelectronVolts) or 208 keV or a combination of the 2 energy peaks). A study on phantom will optimise the reconstruction parameters. These parameters will then be applied to a population of patients who have already benefited from a recording on a 3D CZT camera (retrospective data).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

March 10, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2025

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

1 month

First QC Date

January 14, 2025

Last Update Submit

December 17, 2025

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Demonstrate that the quantification of images obtained with the 113 keV peak is equivalent to the quantification obtained with the 208 keV peak.

    Measurement of contrast coefficients and metabolic volumes on reconstructed images

    one day

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who have already benefited from at least one course of lutetium vipivotide tetraxetan and a recording on a 3D Cadmium Zinc Telluride camera made the day after treatment (image on Day N°1, Day 0 being the day of treatment administration)

You may qualify if:

  • Patients treated by at least one cure of lutetium vipivotide tetraxetan with imaging

You may not qualify if:

  • Patient having sent an objection to the use of their data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chru Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

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

January 14, 2025

First Posted

January 20, 2025

Study Start

March 10, 2025

Primary Completion

April 10, 2025

Study Completion

May 12, 2025

Last Updated

December 23, 2025

Record last verified: 2025-12

Locations

FR(1)