Clinical trial · Interventional
68Ga-NOTA-RM26 PET/CT in Prostate Cancer Patients
Safety and Diagnostic Performance of 68Gallium-labeled NOTA-RM26 PET/CT in Prostate Cancer Patients
NCT03164837CI-TRIAL-00027779unknownPhase 1ClinicalTrials.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)
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-RM26 in prostate cancer patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-RM26 will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-NOTA-RM26 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-NOTA-RM26 PET/CT
- description
- The patients were injected with 111-148 MBq of 68Ga-NOTA-RM26 in one dose intravenously and underwent PET/CT scan 15-30 min later.
- interventionNames
- Drug: 68Ga-NOTA-RM26
Primary outcomes (1)
- measure
- Standardized uptake value of 68Ga-NOTA-RM26 in prostate cancer
- timeFrame
- 1 year
- description
- The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in prostate cancer will be measured.
Secondary outcomes (1)
- measure
- Adverse events collection
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with diagnosis of primary prostate cancer having a prostate neoplasm identified by ultrasound or MRI, being diagnosed by needle biopsy as having prostate cancer, having undergone whole-body bone scanning, and being able to provide basic information and sign the written informed consent form. Exclusion Criteria: * The exclusion criteria included claustrophobia, kidney or liver failure, and inability to fulfill the study.
References
Publications (0)
Data not yet available
No reference posted for this study.