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

SPECT Imaging of Prostate-Specific Membrane Antigen Using Labeled Technetium-99m BQ0413 ([99mTc]Tc- BQ0413) in Prostate Cancer Patients

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Whole body study and SPECT with [99mTc]Tc-BQ0413

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Russian Federation
  • Tomsk, Russian Federation
    • TomskNRMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Prostate cancer 50 mkg; At least five (5) evaluable subjects with prostate cancer with [99mTc]Tc-BQ0413 (50 mkg)	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.; Other Names: Diagnostic Test:
Experimental: Experimental: Prostate cancer 100 mkg; At leaAt least five (5) evaluable subjects with prostate cancer with [99mTc]Tc-BQ0413 (100 mkg)	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.; Other Names: Diagnostic Test:

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gamma camera-based whole-body [99mTc]Tc-BQ0413 uptake value (%)	Whole-body [99mTc]Tc-BQ0413 uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical	24 hours
SPECT-based [99mTc]Tc-BQ0413 value in tumor lesions (counts)	[99mTc]Tc-BQ0413 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts	6 hours
SPECT-based [99mTc]Tc-BQ0413 uptake value (counts)	Focal uptake of [99mTc]Tc-BQ0413 in the regions without pathological findings will be assessed with SPECT and measured in counts	6 hours
Tumor-to-background ratio (SPECT)	The SPECT-based tumor-to-background ratio will be calculated as follows: the value of [99mTc]Tc-BQ0413 uptake coinciding with tumor lesions (counts) will be divided by the value of [99mTc]Tc-BQ0413 uptake coinciding with the regions without pathological findings (counts)	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of cases with abnormal findings relative to baseline [Safety and Tolerability]	The safety attributable to [99mTc]Tc-BQ0413 injections will be evaluated based on the assessments of physical examination, vital signs, and ECG (percent of cases with abnormal findings relative to baseline)	24 hours
Percent of participants with abnormal laboratory values that are related to diagnostic imaging procedure [Safety and Tolerability]	The safety attributable to [99mTc]Tc-BQ0413 injections will be evaluated based on the blood and urine laboratory tests (percent of cases with abnormal findings relative to baseline)	24 hours
Percent of participants with adverse events that are related to diagnostic imaging procedure [Safety and Tolerability]	The safety attributable to [99mTc]Tc-BQ0413 injections will be evaluated based on the rate of adverse events (percent)	24 hours
Percent of participants requiring administration of medication due to side effects that are related to diagnostic imaging procedure [Safety and Tolerability]	The safety attributable to [99mTc]Tc-BQ0413 injections will be evaluated based on the rate of administration of concomitant medication (percent)	24 hours

Collaborators and Investigators

• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Collaborators: Uppsala University
• Investigators: Study Director: Vladimir I Chernov, MD,Prof, Tomsk NRMC

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Prostate cancer; SPECT; Prostate-Specific Membrane Antigen; [99mTc]Tc-BQ0413
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: [99mTc]Tc- BQ0413

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No