Recruiting

TRAQinform Theranostics

Sponsor:

AIQ Solutions

Code:

NCT06815354

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TRAQinform Theranostics

Study Details

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

Study ID

NCT06815354

Start date

Dec 2, 2024

Status verified date

Sep, 2025

Completion date

May 29, 2026

Anticipated

Primary completion date

Mar 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

32 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Metastatic Prostate Cancer

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

Interventions

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 measure

  • Investigate intent to change treatment decisions after the addition of the TRAQinform Theranostics [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Dona Alberti, RN, MSN

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

Tim Perk, PhD

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

Locations

Weill Medical College of Cornell

Recruiting

New York, New York, United States, 10065

Contacts

GU Oncology Program

646-962-2072guonc@med.cornell.edu

Sarah Yuan

646-962-6040say7008@med.cornell.edu

M.D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Paul Corn, MD

713-563-7208pcorn@mdanderson.org

More Information

Sponsor

AIQ Solutions

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Keywords

  • Prostate Cancer
  • Theranostics
  • PET/CT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AIQ Solutions on 2025-09-09.