NCT06815354 · AIQ Solutions
Comprehensive Assessment of Cancer Theranostic Response
(TRAQinform)
What this study is about
The intent of this study is to evaluate actionable outputs from TRAQinform Theranostics in a forward-looking, multi-center, non-interventional clinical study. The primary objective is to investigate intent-to-change treatment decisions after the addition of TRAQinform Theranostics.
View original scientific description
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.
Interventions
DEVICE
TRAQinform 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.
Primary outcome measures
Investigate intent to change treatment decisions after the addition of the TRAQinform Theranostics
Time frame: 12 weeks
Medical teams make a treatment decision using the PSMA PET/CT, diagnostic CT, and other clinical data without the TRAQinform Theranostics analysis report. A treatment decision questionnaire is completed. The medical team is then given the TRAQinform Theranostic report, and the treatment decision questionnaire is completed again. TRAQinform Theranostic analyzes PSMA PET/CT and CTs. A pdf report allows a medical team to view and interpret the TRAQinform outputs. The report is a theranostic tracer concordance analysis of the PSMA PET/CT and the diagnostic CT for lesions and organs. PSMA PET/CT metrics include SUVmax, SUVmean, Volume and Slice. CT metrics include Volume and Slice. Treatment decisions with/without TRAQinform Theranostics report will be evaluated by calculating the Kappa Index, reported with corresponding 95% confidence interval. Logistic regression analysis will be conducted to correlate decisions with outcomes.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- New York, New York
- Houston, Texas
Collaborators
National Cancer Institute (NCI), Weill Medical College of Cornell University, M.D. Anderson Cancer Center
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 9, 2025 · Source of record for eligibility and locations