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

NCT ID: NCT06101927

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-19
• Study Completion Date: 2024-12-30

Brief 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.

Detailed Description

The overall goal is to study the effectiveness of SPECT imaging prostate cancer patients Using technetium-99m labeled BQ0413.

Phase I of the study:

Biodistribution of [99mTc]Tc-BQ0413 in patients with prostate cancer.

The main objectives of the study:

1. To evaluate the distribution of [99mTc]Tc-BQ0413 in normal tissues and tumors in patients with prostate cancer at different time intervals.

2. To evaluate dosimetry of [99mTc]Tc-BQ0413 based on the pharmacokinetic parameters of the drug after a single intravenous administration.

3. To study the safety of use and tolerability of the drug [99mTc]Tc-BQ0413 after a single intravenous administration in a diagnostic dosage.

Additional research tasks:

1. To conduct a comparative analysis of the diagnostic information obtained in the visualization of prostate cancer by SPECT using [99mTc]Tc-BQ0413 with data obtained by CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) research of postoperative material.

Methodology:

Open-label, exploratory, single centre study. The subjects will receive a single injection of the labeled tracer.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Experimental: Prostate cancer 50 mkg

At least five (5) evaluable subjects with prostate cancer with \[99mTc\]Tc-BQ0413 (50 mkg)

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Experimental: Prostate cancer 100 mkg

At leaAt least five (5) evaluable subjects with prostate cancer with \[99mTc\]Tc-BQ0413 (100 mkg)

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Diagnostic Test:

Eligibility Criteria

Inclusion Criteria

• Subject is > 18 years of age
• Clinical and radiological diagnosis of prostate cancer with histological verification.
• White blood cell count: > 2.0 x 10^9/L
• Haemoglobin: > 80 g/L
• Platelets: > 50.0 x 10^9/L
• Bilirubin =< 2.0 times Upper Limit of Normal
• Serum creatinine: Within Normal Limits
• Blood glucose level not more than 5.9 mmol/L
• Subject is capable to undergo the diagnostic investigations to be performed in the study
• Informed consent

Exclusion Criteria

• Active current autoimmune disease or history of autoimmune disease
• Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening)
• Known HIV positive or chronically active hepatitis B or C
• Administration of other investigational medicinal product within 30 days of screening
• Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: collaborator

Tomsk National Research Medical Center of the Russian Academy of Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vladimir I Chernov, MD,Prof

Role: STUDY_DIRECTOR

Tomsk NRMC

Locations

TomskNRMC

Tomsk, , Russia

Countries

Russia

Other Identifiers

[99mTc]Tc- BQ0413

Identifier Type: -

Identifier Source: org_study_id