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Comprehensive Assessment of Cancer Theranostic Response; Investigating the Intent to Change Treatment Decisions Based on TRAQinform Theranostics

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
New York
Weill Medical College of Cornell
RECRUITING
New York
Texas
M.D. Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Dona Alberti, RN, MSN
dona.alberti@aiq-solutions.com
608-268-9684
Backup
Tim Perk, PhD
tim.perk@aiq-solutionsc.com
608-268-9684
Time Frame
Start Date: 2024-12-02
Estimated Completion Date: 2026-05-29
Participants
Target number of participants: 32
Treatments
Other: Metastatic Prostate Cancer
32 patients with metastatic prostate cancer planned to start treatment with 177Lu-PSMA (Pluvicto) will be enrolled.
Related Therapeutic Areas
Sponsors
Collaborators: Weill Medical College of Cornell University, National Cancer Institute (NCI), M.D. Anderson Cancer Center
Leads: AIQ Solutions

This content was sourced from clinicaltrials.gov