Comprehensive Assessment of Cancer Theranostic Response
Recruiting · NCT06815354 · Interventional (participants receive a specific treatment) · Lead sponsor: AIQ Solutions
View the official record on ClinicalTrials.gov →Interventions studied
TRAQinform Theranostics
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
2 locations listed across 2 US states.
- Weill Medical College of Cornell - New York, New York, United States
- M.D. Anderson Cancer Center - Houston, Texas, United States