Status:
COMPLETED
Investigation of PSMA PET/CT as an Imaging Biomarker in Solid Tumors
Lead Sponsor:
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Conditions:
Prostate-specific Membrane Antigen
mCRPC or Advanced/Metastatic Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
multi-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...
Detailed Description
Multi-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...
Eligibility Criteria
Inclusion
- Patients with mCRPC or advanced/metastatic solid tumors;
- Male or Female, aged \>18 years;
- Written informed consent;
- Relapse or progression of disease on CT scan and / or MRI;
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Exclusion
- Pregnancy / Nursing;
- Participation in another clinical trial with any investigational agents within 30 days prior to study entry
- Medical or psychological conditions that would not allow the participant to understand, or sign the informed consent.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga-PSMA or other agents used in the study.
- inability to remain still for the entire duration of the exam
Key Trial Info
Start Date :
July 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2025
Estimated Enrollment :
1225 Patients enrolled
Trial Details
Trial ID
NCT03453528
Start Date
July 4 2017
End Date
January 3 2025
Last Update
January 8 2025
Active Locations (1)
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1
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola, FC, Italy, 47014