CompletedPhase 1

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

Russia10 participantsStarted 2023-10-19

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 24 hours

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

Timeframe: 6 hours

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

Timeframe: 6 hours

Tumor-to-background ratio (SPECT)

Timeframe: 6 hours

Trial details

NCT IDNCT06101927

SponsorTomsk National Research Medical Center of the Russian Academy of Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-31

View on ClinicalTrials.gov More Prostate Cancer trials

Plain-language summary

Who can participate

Age range

18 Years – 75 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.