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Molecular Imaging of Prostate-Specific Membrane Antigen Using Labeled Technetium-99m BQ0413

NCT06101927 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-04-09

No results posted yet for this study

Summary

The study should evaluate the biological distribution of \[99mTc\]Tc-BQ0413 in patients with prostate cancer.

The primary objective are:

1. To assess the distribution of \[99mTc\]Tc- BQ0413 in normal tissues and tumors at different time intervals.
2. To evaluate dosimetry of \[99mTc\]Tc- BQ0413.
3. To study the safety and tolerability of the drug \[99mTc\]Tc- BQ0413 after a single injection in a diagnostic dosage.

The secondary objective are:

1\. To compare the obtained \[99mTc\]Tc- BQ0413 SPECT imaging results with the data of CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) studies in prostate cancer patients.

Conditions

Interventions

DRUG

Whole body study and SPECT with [99mTc]Tc-BQ0413

One single intravenous injection of \[99mTc\]Tc-BQ0413, followed by gamma camera imaging after 2, 4, 6 and 24 hours.

Sponsors & Collaborators

  • Uppsala University

    collaborator OTHER

  • Tomsk National Research Medical Center of the Russian Academy of Sciences

    lead OTHER

Principal Investigators

  • Vladimir I Chernov, MD,Prof · Tomsk NRMC

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-19
Primary Completion
2024-05-31
Completion
2024-12-30

Countries

  • Russia

Study Locations

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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 NCT06101927 on ClinicalTrials.gov