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

NCT ID: NCT06201741

Last Updated: 2024-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-27

Study Completion Date

2024-06-30

Brief Summary

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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

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Conditions

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Prostate Specific Membrane Antigen Positive Metastatic Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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

\[131I\]/\[18F\]/\[68Ga\]ZT-111, single dose

Group Type EXPERIMENTAL

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

Intervention Type RADIATION

\[131I\]/\[18F\]/\[68Ga\]ZT-111, single dose

Interventions

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

\[131I\]/\[18F\]/\[68Ga\]ZT-111, single dose

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

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YiHui Guan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Huashan Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yihui Guan, MD

Role: CONTACT

+86 13764308300

Facility Contacts

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Yihui Guan, MD

Role: primary

13764308300 ext. +86

Other Identifiers

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KY2023-1018

Identifier Type: -

Identifier Source: org_study_id

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