Clinical trial · Interventional
68Ga-PSMA PET/CT for Ra223 Assessment
Using 68Ga-PSMA PET/CT for the Assessment of Osseous Tumor Burden in mCRPC Patients Undergoing 223Ra-dichloride Injections
NCT04951817CI-TRIAL-00094311unknownN/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)
Primary objective: i.The primary objective is to compare the diagnostic positivity in progression of 68Ga-PSMA PET and Bone scan. Secondary objectives: i.The correlation between PET osseous tumor burden index and Alk-P level ii.The correlation between PET osseous tumor burden index and PSA level
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 |
|---|---|---|---|
| Metastatic Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ga-68 PSMA ligand | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ga68-PSMA ligand
- description
- Glass vial with 5\~20 mCi(185-740 MBq) of 68Ga-PSMA ligand in ≤10% EtOH with aqueous sterile water for injection solution (approximately 15.5 mL), ≧ 0.33 mCi/mL @ EOS。
- interventionNames
- Drug: Ga-68 PSMA ligand
Primary outcomes (1)
- measure
- Change of lesion detection number by PET imaging
- timeFrame
- 9-11 weeks or 21-23 weeks
- description
- Lesion detection number before and under Ra223 therapy on the PSMA PET imaging with a time interval 9-11 weeks and/or 21-23 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Males with 40-85 years of age and life expectancy more than 3 months 2. Patient was diagnosed as mCRPC, and meet the standard criteria of using 223Ra-dichloride (symptomatic bone metastasis, at least two bone metastasis sites, no visceral organ metastasis) 3. Willing to sign the informed consent 4. ECOG performance status Grade 0-2 Exclusion Criteria: 1. Unable to tolerate the PET/CT scan, such as those with claustrophobia, unable to lie still, consciousness unclear, vital sign unstable. 2. With renal impairment (glomerular filtration rate lower than 30 ml/min/1.73 m2), and allergy to medium contrast. 3. Significant abnormal lab data (AST or ALT more than three times of normal value), and high risk to conduct examination after evaluations of PI. 4. Patient had previous other malignancy history 5. Patient experiences grade 3-4 neutropenia (neutrophil counts less than 1000/uL) or thrombocytopenia (platelet counts less than 50x103/uL) lasting \> 14 days
References
Publications (0)
Data not yet available
No reference posted for this study.