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Study of 18F-Florastamin PET/CT Imaging in Patients With at Least Intermediate Risk Prostate Cancer

NCT06011304 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2023-10-23

No results posted yet for this study

Summary

In this study, 18F-Florastamin PET/CT will be performed in patients with at least intermediate risk prostate cancer, to assess the diagnostic performance and safety of 18F-Florastamin PET/CT imaging.

This study will first carry out the pilot study (including pharmacokinetics and radiation dosimetry).

Conditions

Interventions

DRUG

[18F]Florastamin Injection

The subjects who participate in phase 3 study will be intravenously injected with \[18F\]Florastamin Injection and undergo PET/CT scan at 110 min after the injection. Subjects who participate in pilot study will be intravenously injected with \[18F\]Florastamin Injection and undergo PET/CT scan at 5 min, 30 min, 60 min, 110 min, 160 min after the injection.

Sponsors & Collaborators

  • HTA Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-20
Primary Completion
2024-11-30
Completion
2025-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06011304 on ClinicalTrials.gov