Clinical trial · Interventional
Investigation of PSMA PET/CT as an Imaging Biomarker in Solid Tumors
NCT03453528CI-TRIAL-00084464BASKET PSMAcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| mCRPC or Advanced/Metastatic Solid Tumors | — | UNRESOLVED | — |
| Prostate-specific Membrane Antigen | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-PSMA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-PSMA
- description
- 68Ga-PSMA
- interventionNames
- Drug: 68Ga-PSMA
Primary outcomes (1)
- measure
- detection rate of 68Ga-PSMA PET/CT
- timeFrame
- up to 36 months
- description
- the proportion of 68Ga-PSMA- positive patients and the total number of recruited patients in two groups population's (metastatic castration-resistance prostate cancer and various origin solid tumors).
Secondary outcomes (4)
- measure
- Safety is defined as the number and percentage of treated patients undergoing grade 1 to 4 adverse events according to CTCAE version 4.03
- timeFrame
- up to 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.