Clinical trial · Interventional
Preliminary Evaluation of Uptake in Bone Metastases and Biodistribution of [68Ga]P15-041
A Preliminary Evaluation of Uptake in Bone Metastases, Biodistribution and Excretion of the Novel Radiotracer [68Ga]P15-041 by PET/CT
NCT02826382CI-TRIAL-00063167completedEarly Phase 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)
A phase1 study to demonstrate \[68Ga\]P15-041 binding to bone metastases in prostate cancer and determination of human dosimetry.
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 |
|---|---|---|---|
| Bone Metastases | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga]P15-041 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dynamic imaging group
- description
- Dynamic imaging of suspected bone metastases with the investigation drug \[68Ga\]P15-041
- interventionNames
- Drug: [68Ga]P15-041
- type
- EXPERIMENTAL
- label
- Whole body dosimetry group
- description
- Determination of human dosimetry of the investigation drug \[68Ga\]P15-041
- interventionNames
- Drug: [68Ga]P15-041
Primary outcomes (2)
- measure
- Time course of uptake of [68Ga]P15-041 in bone metastases
- timeFrame
- 60 minutes post injection
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically confirmed prostate cancer. known or suspected bone metastases referred for a clinical \[99mTc\]MDP scan Exclusion Criteria: * Estimated creatinine clearance (GFR) \< 30 mL/min (calculated), history of hyperparathyroidism, • Inability to tolerate imaging procedures in the opinion of an investigator or treating physician, • Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
References
Publications (0)
Data not yet available
No reference posted for this study.