NCT03453528Completed
Investigation of PSMA PET/CT as an Imaging Biomarker in Solid Tumors
Source: ClinicalTrials.gov · Last updated 8 Jan 2025
Brief summary (registry, in English)
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/metastatic solid tumors patients.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 1225 (actual)
- First submitted
- 27 Feb 2018
- Start date
- 4 Jul 2017
- Primary completion date
- 4 Dec 2024
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Diseases
- Prostate cancer
- NCT number
- NCT03453528
What you commit to
- Study type: Interventional
- Participants enrolled: 1225
- From 4 Jul 2017 to the primary completion date, 4 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another clinical trial with any investigational agents within 30 days prior to study entry
Other illness
- 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.
Other
- Pregnancy / Nursing;
- inability to remain still for the entire duration of the exam
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Coordinator of this site? Confirm its status | Meldola | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.