Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT06815354

Comprehensive Assessment of Cancer Theranostic Response

Led by AIQ Solutions · Updated on 2025-09-09

32

Participants Needed

2

Research Sites

77 weeks

Total Duration

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Sponsors

A

AIQ Solutions

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Comprehensive Assessment of Cancer Theranostic Response

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older and willing and able to provide informed consent.
  • Diagnosis of metastatic prostate cancer.
  • Planned to start 177Lu-PSMA (Pluvicto) treatment.
  • Ability to tolerate two 68Ga-PSMA or 18F-DCFPyL PET/CT imaging procedures, one at baseline and one at 12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at screening.
Not Eligible

You will not qualify if you...

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

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Trial Site Locations

Total: 2 locations

1

Weill Medical College of Cornell

New York, New York, United States, 10065

Actively Recruiting

2

M.D. Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

D

Dona Alberti, RN, MSN

CONTACT

T

Tim Perk, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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