Clinical trial · Interventional
68Ga PET/CT Imaging in Breast Cancer Patients
68Ga-P16-093 PET/CT Imaging in Primary and Recurrent Breast Cancer Patients
NCT05622227CI-TRIAL-00062252unknownPhase 1 / Phase 2ClinicalTrials.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)
PSMA is highly expressed on the cell surface of the microvasculature of several solid tumors, including breast cancer. This makes it a potentially imaging target for the detection and grading of breast cancer. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with 18F-FDG in the same group of breast cancer patients.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drug: 68Ga-P16-093 | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-P16-093 and 18F-FDG scan
- description
- Within 1 week, each patient underwent 68Ga-P16-093 and 18F-FDG PET/CT scan after intravenous administration of 68Ga-P16-093 and 18F-FDG, respectively.
- interventionNames
- Diagnostic Test: Drug: 68Ga-P16-093
Primary outcomes (1)
- measure
- Diagnostic performance
- timeFrame
- through study completion, an average of 1 year
- description
- comparing the number of tumor detected by 68Ga-P16-093 and 18F-FDG
Secondary outcomes (1)
- measure
- standardized uptake value (SUV) of tumor
- timeFrame
- through study completion, an average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * breast cancer patients highly suggested by ultrasound or histologically confirmed; * 68Ga-P16-093 PET/CT and 18F-FDG within two weeks; * signed written consent. Exclusion Criteria: * known allergy against PSMA; * any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
References
Publications (0)
Data not yet available
No reference posted for this study.