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

January 23, 2024 updated by: YiHui Guan, Huashan Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Huashan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [131I]/[18F]/[68Ga]ZT-111
[131I]/[18F]/[68Ga]ZT-111, single dose
Radiation: [131I]/[18F]/[68Ga]ZT-111
[131I]/[18F]/[68Ga]ZT-111, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dosimetry
Time Frame: About 24hours from time of injection
Whole body and organ uptake activity
About 24hours from time of injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of adverse events
Time Frame: 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
From administration of [131I]/[18F]/[68Ga]ZT-111 until 1 week after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2023

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Actual)

January 11, 2024

Study Record Updates

Last Update Posted (Actual)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2023-1018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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