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

Study Overview
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Brief Summary
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The study should evaluate the biological distribution of [99mTc]Tc-BQ0413 in patients with prostate cancer. The primary objective are: To assess the distribution of [99mTc]Tc- BQ0413 in normal tissues and tumors at different time intervals. To evaluate dosimetry of [99mTc]Tc- BQ0413. 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
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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: 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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Whole body study and SPECT with [99mTc]Tc-BQ0413


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Prostate cancer 50 mkg<br>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<br>* One single intravenous injection of [99mTc]Tc-BQ0413, followed by gamma camera imaging after 2, 4, 6 and 24 hours.<br>* Other names: Diagnostic Test:;|
| Experimental: Experimental: Prostate cancer 100 mkg<br>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<br>* One single intravenous injection of [99mTc]Tc-BQ0413, followed by gamma camera imaging after 2, 4, 6 and 24 hours.<br>* Other names: Diagnostic Test:;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate-Specific Membrane Antigen, Prostate cancer, [99mTc]Tc-BQ0413, SPECT