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Clinical Trials in the USA / NCT06815354
Active, not recruiting Not applicable

Comprehensive Assessment of Cancer Theranostic Response

NCT06815354 · tracked via the Priya Life Science USA tracker
Sponsor
AIQ Solutions
Phase
Not applicable
Started
2024-12-02
Last updated
2026-10-06

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

TRAQinform Theranostics

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.

Study 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

Sex
MALE
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

  • Investigate intent to change treatment decisions after the addition of the TRAQinform Theranostics — 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.

Trial sites (2)

FacilityCityRegionStatus
Weill Medical College of Cornell New York New York
M.D. Anderson Cancer Center Houston Texas

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dMD-002 Pilot Study in Patients With Cavernous Nerve Injury Following Radical Prostatectomy Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06815354 on ClinicalTrials.gov ↗ ← All trials in the USA