Comprehensive Assessment of Cancer Theranostic Response
Comprehensive Assessment of Cancer Theranostic Response; Investigating the Intent to Change Treatment Decisions Based on TRAQinform Theranostics
AIQ Solutions
32 participants
Dec 2, 2024
INTERVENTIONAL
Conditions
Summary
The intent of this study is to evaluate actionable outputs from TRAQinform Theranostics in a prospective, multi-center, non-interventional clinical study. The primary objective is to investigate intent-to-change treatment decisions after the addition of TRAQinform Theranostics. The exploratory objective is to investigate if treatment efficacy and treatment-related toxicity could be detected by TRAQinform Theranostics following PSMA PET/CT at week 12.
Eligibility
Inclusion Criteria5
- Age 18 years or older and willing and able to provide informed consent.
- Diagnosis of metastatic prostate cancer.
- Planned to start 177Lu-PSMA (Pluvicto).
- Ability to tolerate two 68Ga-PSMA or 18F-DCFPyL PET/CT imaging procedures. One at baseline and at 12 weeks of 177Lu-PSMA (Pluvicto) treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 at screening.
Exclusion Criteria1
- Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial.
Interventions
This prospective, multi-center, non-interventional clinical study will evaluate actionable outputs from TRAQinform Theranostics, a software only medical device that identifies, quantifies, tracks, and compares lesions between different imaging modalities and multiple imaging timepoints.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06815354