68Ga-PSMA PET/CT for Ra223 Assessment
Recruiting · NCT04951817 · Interventional (participants receive a specific treatment) · Lead sponsor: Chang Gung Memorial Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Ga-68 PSMA ligand
What this trial is about
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
Who can take part
Age range
40 Years to 85 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Males with 40-85 years of age and life expectancy more than 3 months
- 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)
- Willing to sign the informed consent
- ECOG performance status Grade 0-2
Exclusion criteria
- Unable to tolerate the PET/CT scan, such as those with claustrophobia, unable to lie still, consciousness unclear, vital sign unstable.
- With renal impairment (glomerular filtration rate lower than 30 ml/min/1.73 m2), and allergy to medium contrast.
- Significant abnormal lab data (AST or ALT more than three times of normal value), and high risk to conduct examination after evaluations of PI.
- Patient had previous other malignancy history
- Patient experiences grade 3-4 neutropenia (neutrophil counts less than 1000/uL) or thrombocytopenia (platelet counts less than 50x103/uL) lasting \> 14 days
Where it is running
1 location listed.
- Chang Gung Memorial Hospital ,Linkou - Taoyuan City, Taiwan