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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06268418
Acronym
PADL
Enrollment
46
Registered
2024-02-20
Start date
2024-11-30
Completion date
2025-06-30
Last updated
2025-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radionucleide Therapy

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

Detailed description

Despite the early success of TRT, concerns have been raised about the risks of inadequate trade-off between therapeutic dose and side effects. Currently, the protocols for administering the radiopharmaceuticals are assessed on a population basis, and the activity to administer was determined for a specific patient group based on preceding studies . However, the European Council Directive (2013/59 Euratom) mandates that TRT treatments should be planned according to the optimal radiation dose tailored for individual patients, as has long been the case for external beam radiotherapy (EBRT) or brachytherapy. An essential requirement of TRT treatment planning is to estimate the absorbed dose in advance of therapy. Prior knowledge of the biodistribution of the therapeutic agent via the pre-therapy imaging assists to optimize the trade-off between tumor destruction and irradiation of healthy tissues. Concepts, such as physiologically based pharmacokinetic (PBPK) modeling, have been proposed to estimate the spatiotemporal pharmacokinetics of imaging agents and then extrapolate to the treatment agents. An alternative is to generate a 3D time integrated activity (TIA) map per patient based on the PBPK and the pre-therapy imaging. The TIA gives the information about number of decays that take place in each voxel during the total duration of the therapy. PBPK is an organ-based model, then the calculation of the 3D TIA raises the issue of organ segmentations on the pre-therapy nuclear imaging, which must be robust, automatic, and accurate. The absorbed dose to the patient can be estimated before the treatment using the 3D TIA and the patient anatomy (CT image) using Monte Carlo (MC) simulation. . This project will address two main challenges: (a) the robust and accurate metabolic segmentation in nuclear medicine for the 3D TIA calculation, and (b) the fast dose prediction based on MC and deep-learning approach.

Interventions

OTHERArtificial intelligence

Segmentation

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the prediction of the absorbed dose by Deep Learning approaches for RLT with 177Lu-PSMA, from pre-treatment 68Ga-PSMA.PET/CT images1 monthDifference between the dose prediction by the model and that calculated with a reference method (Monte Carlo)

Secondary

MeasureTime frameDescription
Automatically contour the total tumor metabolic volume on 68Ga-PSMA pretreatment PET images using Deep Learning approaches1 monthDice index between the reference contour and that given by the model

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026