Comprehensive Assessment of Cancer Theranostic Response

NCT06815354 | Recruiting FDA Device

• 2 other identifiers: AIQ 24-32165R44CA285006-02
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Theranostics; PET/CT

Outcome Measures

Primary Outcomes (1)

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

  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.

  12 weeks

Secondary Outcomes (1)

• Investigate if treatment efficacy and treatment-related toxicity could be detected by the TRAQinform Theranostics

  12 weeks

Study Arms (1)

Metastatic Prostate Cancer

OTHER

32 patients with metastatic prostate cancer planned to start treatment with 177Lu-PSMA (Pluvicto) will be enrolled.

Device: TRAQinform Theranostics

Interventions

TRAQinform Theranostics DEVICE

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.

Metastatic Prostate Cancer

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial.

Sponsors & Collaborators

• AIQ Solutions: lead
• National Cancer Institute (NCI): collaborator
• Weill Medical College of Cornell University: collaborator
• M.D. Anderson Cancer Center: collaborator

Study Sites (2)

Weill Medical College of Cornell

New York, New York, 10065, United States

RECRUITING

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Dona Alberti, RN, MSN

CONTACT

608-268-9684; dona.alberti@aiq-solutions.com

Tim Perk, PhD

CONTACT

608-268-9684; tim.perk@aiq-solutionsc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Recruited patients will receive a PSMA PET/CT at week 12 in addition to SOC baseline PSMA PET/CT and diagnostic CT and week 12 diagnostic CT images. After each follow-up PET/CT, the local team will make a clinical decision about the care of the patient, using the PET/CT images and other relevant clinical data, but without information provided by TRAQinform Theranostics, and answer a investigator questonnaire. The design is modeled after intent-to-change studies con-ducted by the National Oncology PET Registry (NOPR).

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 7, 2025
• Study Start: December 2, 2024
• Primary Completion: March 30, 2026
• Study Completion (Estimated): May 29, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

US (2)