A Study to Evaluate the Human Biodistribution and Dosimetry of the Radionuclide Labeled ZT-111 in Patients With Metastatic Prostate Cancer
Not Applicable
Recruiting
- Conditions
- Prostate Specific Membrane Antigen Positive Metastatic Prostate Cancer
- Interventions
- Radiation: [131I]/[18F]/[68Ga]ZT-111
- Registration Number
- NCT06201741
- Lead Sponsor
- Huashan Hospital
- Brief Summary
This study is to evaluate the safety, biodistribution, radiation dosimetry and tumor uptake of the \[131I\]/\[18F\]/\[68Ga\]ZT-111 in patients with PSMA positive metastatic prostate cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 10
Inclusion Criteria
- Age between 18 and 65 years old.
- Histologically or cytologically confirmed prostate adenocarcinoma with documented history of ≥1 metastatic lesions indicated by imaging.
- Informed consent must be obtained in writing from the subject, their legally authorized representative, or caregiver.
- Willing and able to comply with all aspects of this study.
Exclusion Criteria
- Severe hepatic or renal impairment.
- History of major surgery within the last month.
- Participation in another concurrent clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description [131I]/[18F]/[68Ga]ZT-111 [131I]/[18F]/[68Ga]ZT-111 \[131I\]/\[18F\]/\[68Ga\]ZT-111, single dose
- Primary Outcome Measures
Name Time Method Dosimetry About 24hours from time of injection Whole body and organ uptake activity
- Secondary Outcome Measures
Name Time Method Incidence and severity of adverse events From administration of [131I]/[18F]/[68Ga]ZT-111 until 1 week after injection Incidence and severity of adverse events (AEs) as assessed by CTCAE v5.0
Trial Locations
- Locations (1)
Huashan Hospital
🇨🇳Shanghai, China