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Evaluate the Clinical Usefulness of [F-18]Florastamin PET/CT Imaging Diagnosis Compared to MRI Diagnosis

NCT05004285 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 398

Last updated 2025-03-12

No results posted yet for this study

Summary

Only in subjects who satisfy the inclusion/exclusion criteria, a single dose of \[F-18\]Florastamin at 10 ± 1 mCi is IV administered at Visit 2, and \[F-18\]Florastamin PET/CT images are obtained from the head to thigh after 110 ± 10 minutes.

Conditions

  • High Risk Prostate Carcinoma

Interventions

DRUG

[F-18]Florastamin

A single dose of \[F-18\]Florastamin at 10 ± 1 mCi is IV administered at Visit 2, and \[F-18\]Florastamin PET/CT images are obtained from the head to thigh after 110 ± 10 minutes.

Sponsors & Collaborators

  • FutureChem

    lead INDUSTRY

Principal Investigators

  • Ji Youl Lee, Ph.D · The Catholic University of Korea

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-28
Primary Completion
2025-06-01
Completion
2025-06-01

Countries

  • South Korea

Study Locations

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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 NCT05004285 on ClinicalTrials.gov