Pre-therapeutic 68Ga-PSMA PET AI Based Dose Prediction for 177Lu-PSMA Targeted Radionuclide Therapy

NCT06268418 | Completed

• 1 other identifier: 2024PI020
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

Targeted Radionuclide Therapy (TRT) is a contemporary approach to radiation oncology, aiming to deliver the maximal destructive radiation dose via cancer-targeting radiopharmaceutical. Radioactive ligands for the prostate-specific membrane antigen (PSMA) have emerged for the treatment of metastatic castration-resistant prostate cancer (mCRPC).Normal organ and tumor dose can be assessed by a series of cross-sectional whole-body SPECT scans, however, these require a large amount imaging time and are often not feasible in routine clinical practice. An alternative is to generate a 3D time integrated activity (TIA) map per patient based on the PBPK and the pre-therapy imaging

Conditions

Radionucleide Therapy

Outcome Measures

Primary Outcomes (1)

• Evaluate the prediction of the absorbed dose by Deep Learning approaches for RLT with 177Lu-PSMA, from pre-treatment 68Ga-PSMA.PET/CT images

  Difference between the dose prediction by the model and that calculated with a reference method (Monte Carlo)

  1 month

Secondary Outcomes (1)

• Automatically contour the total tumor metabolic volume on 68Ga-PSMA pretreatment PET images using Deep Learning approaches

  1 month

Interventions

Artificial intelligence OTHER

Segmentation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who received at least one dose of 177Lu-PSMA and for whom a 68Ga-PSMA PET/CT was performed as part of IVRT in the "pre-treatment" assessment between 1 2022 and 31 January 2024

You may qualify if:

• Patients who received at least one dose of 177Lu-PSMA and for whom a 68Ga-PSMA PET/CT was performed as part of IVRT in the "pre-treatment" assessment

You may not qualify if:

• Patient opposition to the use of their data as part of this research.

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

MeSH Terms

Interventions

Artificial Intelligence

Intervention Hierarchy (Ancestors)

Algorithms; Mathematical Concepts

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 13, 2024
• First Posted: February 20, 2024
• Study Start: November 30, 2024
• Primary Completion: April 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

FR (2)