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Completed

NCT Number: NCT06101927

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

TomskNRMC

Tomsk, Russia

About this study

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:

  • To evaluate the distribution of [99mTc]Tc-BQ0413 in normal tissues and tumors in patients with prostate cancer at different time intervals.
  • To evaluate dosimetry of [99mTc]Tc-BQ0413 based on the pharmacokinetic parameters of the drug after a single intravenous administration.
  • 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:

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

Other names: Diagnostic Test:

Primary outcomes

  1. Gamma camera-based whole-body [99mTc]Tc-BQ0413 uptake value (%)

    Time frame: 24 hours

    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

  2. SPECT-based [99mTc]Tc-BQ0413 value in tumor lesions (counts)

    Time frame: 6 hours

    [99mTc]Tc-BQ0413 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts

  3. SPECT-based [99mTc]Tc-BQ0413 uptake value (counts)

    Time frame: 6 hours

    Focal uptake of [99mTc]Tc-BQ0413 in the regions without pathological findings will be assessed with SPECT and measured in counts

  4. Tumor-to-background ratio (SPECT)

    Time frame: 6 hours

    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)

Secondary outcomes

  1. Percent of cases with abnormal findings relative to baseline [Safety and Tolerability]

    Time frame: 24 hours

    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)

  2. Percent of participants with abnormal laboratory values that are related to diagnostic imaging procedure [Safety and Tolerability]

    Time frame: 24 hours

    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)

  3. Percent of participants with adverse events that are related to diagnostic imaging procedure [Safety and Tolerability]

    Time frame: 24 hours

    The safety attributable to [99mTc]Tc-BQ0413 injections will be evaluated based on the rate of adverse events (percent)

  4. Percent of participants requiring administration of medication due to side effects that are related to diagnostic imaging procedure [Safety and Tolerability]

    Time frame: 24 hours

    The safety attributable to [99mTc]Tc-BQ0413 injections will be evaluated based on the rate of administration of concomitant medication (percent)

Sponsors and collaborators

Lead sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Other

Collaborators

  • Uppsala University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 26, 2023
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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