Comprehensive Assessment of Cancer Theranostic Response; Investigating the Intent to Change Treatment Decisions Based on TRAQinform Theranostics
AIQ Solutions
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.
Description
To fully understand the clinical impact of TRAQinform Theranostics on a clinical workflow, 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. The primary objective of this clinical study is to investigate intent-to-change treatment decisions after the addition of TRAQinform Theranostics. The exploratory objective is to investigate if treatment efficacy and tre…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * 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 Criteria: * Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial.
Interventions
- DeviceTRAQinform Theranostics
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)
- Weill Medical College of CornellNew York, New York
- M.D. Anderson Cancer CenterHouston, Texas