Comprehensive Assessment of Cancer Theranostic Response

Part of paid clinical trials in New York, New York.

Sponsor
AIQ Solutions
Study ID
NCT06815354
Status
Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Dec 2, 2024
Status verified
Sep 2025
Primary completion
Mar 30, 2026
Completion
May 29, 2026

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: Metastatic Prostate Cancer
    32 patients with metastatic prostate cancer planned to start treatment with 177Lu-PSMA (Pluvicto) will be enrolled.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Weill Medical College of CornellNew YorkNew York10065
GU Oncology Program
646-962-2072
Sarah Yuan
646-962-6040
M.D. Anderson Cancer CenterHoustonTexas77030
Paul Corn, MD
713-563-7208

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