Clinical trial · Observational
A Pilot Study of [Ga-68]PSMA PET/MRI for the Assessment of PSMA-positive Tumors
NCT02978586CI-TRIAL-00051663completedClinicalTrials.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)
The purpose of this study is to see if positron emission tomography/ magnetic resonance imaging (PET/MRI) can be used to monitor the effectiveness of cancer treatment using an investigational radioactive drug called \[Ga-68\]PSMA.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate-specific Membrane Antigen Positive Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [Ga-68]PSMA PET/MR | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- [Ga-68]PSMA PET/MR
- description
- Up to 3 experimental PET/MRI scans will be performed to determine the level of \[Ga-68\]PSMA tumor uptake
- interventionNames
- Device: [Ga-68]PSMA PET/MR
Primary outcomes (1)
- measure
- Test-retest reproducibility of PET biomarker ([Ga68]-PSMA) uptake using PET/MRI
- timeFrame
- Up to 6 weeks after beginning treatment
- description
- The outcome measure for the statistical analysis of the test-retest reproducibility will be concordance analysis of standard uptake values (SUVs) between the 2 baseline scans
Secondary outcomes (7)
- measure
- Test-retest reproducibility of quantification of MRI sequences (multi-parametric MRI)
- timeFrame
- Up to 6 weeks after beginning treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with PSMA-positive tumors including prostate cancer, breast cancer, lung cancer, and other tumor types know to express PSMA * Patients able to tolerate PET/MRI scans * Informed consent must be given and signed Exclusion Criteria: * Subjects who do not meet the above mentioned inclusion criteria * Subjects who refuse to give and/or sign the informed consent * Patients who have a history of serious adverse events related to a previous MRI or PET/CT * Patients who are unable to undergo MRI scanning due to exclusion by institutional MRI restriction policies as mentioned in the standard institutional MRI informed consent form * Patients who are currently pregnant or breast feeding. A pregnancy test within 72 hours of the first PET/MRI will be performed. * Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks. * Renal insufficiency: elevated Creatinine and/or Glomerular Filtration Rate (GFR)\<40ml/min/1.7sqm (exclusion criterion only for contrast enhanced MRI) * Patients with a known allergy against any component of the contrast enhancing MR agent will not receive MR contrast agents. (exclusion criterion only for contrast enhanced MRI)
References
Publications (0)
Data not yet available
No reference posted for this study.