Investigation of 68GaPSMA PET/CT as an Imaging Biomarker in Solid Tumors

• Status: Recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Single-centre, prospective, diagnostic trial to evaluate the Prostate-Specific Membrane Antigen (PSMA-antigen) over-expression in metastatic castration resistant prostate cancer (mCRPC) and in advanced/metastatic solid tumors patients.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Treatments: Gallium 68 PSMA-11

Criteria

Inclusion Criteria:

1. Patients with mCRPC or advanced/metastatic solid tumors;

2. Male or Female, aged >18 years;

3. Written informed consent;

4. Relapse or progression of disease on CT scan and / or MRI;

5. If female of childbearing potential, highly effective birth control methods according to guideline "Recommendation related to contraception and pregnancy testing in clinical trials" (2014_09_15 section 4.1) are mandatory, beginning at the screening visit and continuing until 6 months following last 68Ga-PSMA PET/CT.

6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

1. Pregnancy / Nursing;

2. Participation in another clinical trial with any investigational agents within 30 days prior to study entry

3. Medical or psychological conditions that would not allow the participant to understand, or sign the informed consent.

4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga-PSMA or other agents used in the study.

5. inability to remain still for the entire duration of the exam