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A Study to Evaluate the Human Biodistribution and Dosimetry of the Radionuclide Labeled ZT-111 in Patients With Metastatic Prostate Cancer | Clinical Trials | Clareo Health

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A Study to Evaluate the Human Biodistribution and Dosimetry of the Radionuclide Labeled ZT-111 in Patients With Metastatic Prostate Cancer

NCT06201741•Huashan Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•1. Age between 18 and 65 years old.
•2. Histologically or cytologically confirmed prostate adenocarcinoma with documented history of ≥1 metastatic lesions indicated by imaging.
•3. Informed consent must be obtained in writing from the subject, their legally authorized representative, or caregiver.
•4. Willing and able to comply with all aspects of this study.

Exclusion Criteria

•1. Severe hepatic or renal impairment.
•2. History of major surgery within the last month.
•3. Participation in another concurrent clinical trial.

Locations (1)

Huashan Hospital

Shanghai, China

Key Dates

Start Date

December 27, 2023

Primary Completion Date

April 30, 2024

Completion Date

June 30, 2024

Last Updated

January 25, 2024

Enrollment

ESTIMATED participants

Conditions

Prostate Specific Membrane Antigen Positive Metastatic Prostate Cancer

Interventions

[131I]/[18F]/[68Ga]ZT-111

RADIATION

Contacts

Yihui Guan, MD

CONTACT

+86 13764308300 guanyihui@hotmail.com