Molecular Imaging of Prostate-Specific Membrane Antigen Using Labeled Technetium-99m BQ0413
- Conditions
- Prostate Cancer
- Interventions
- Drug: Whole body study and SPECT with [99mTc]Tc-BQ0413
- Registration Number
- NCT06101927
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 10
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental: Prostate cancer 50 mkg Whole body study and SPECT with [99mTc]Tc-BQ0413 At least five (5) evaluable subjects with prostate cancer with \[99mTc\]Tc-BQ0413 (50 mkg) Experimental: Prostate cancer 100 mkg Whole body study and SPECT with [99mTc]Tc-BQ0413 At leaAt least five (5) evaluable subjects with prostate cancer with \[99mTc\]Tc-BQ0413 (100 mkg)
- Primary Outcome Measures
Name Time Method Gamma camera-based whole-body [99mTc]Tc-BQ0413 uptake value (%) 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
SPECT-based [99mTc]Tc-BQ0413 value in tumor lesions (counts) 6 hours \[99mTc\]Tc-BQ0413 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts
SPECT-based [99mTc]Tc-BQ0413 uptake value (counts) 6 hours Focal uptake of \[99mTc\]Tc-BQ0413 in the regions without pathological findings will be assessed with SPECT and measured in counts
Tumor-to-background ratio (SPECT) 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 Outcome Measures
Name Time Method Percent of participants with adverse events that are related to diagnostic imaging procedure [Safety and Tolerability] 24 hours The safety attributable to \[99mTc\]Tc-BQ0413 injections will be evaluated based on the rate of adverse events (percent)
Percent of participants requiring administration of medication due to side effects that are related to diagnostic imaging procedure [Safety and Tolerability] 24 hours The safety attributable to \[99mTc\]Tc-BQ0413 injections will be evaluated based on the rate of administration of concomitant medication (percent)
Percent of participants with abnormal laboratory values that are related to diagnostic imaging procedure [Safety and Tolerability] 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)
Percent of cases with abnormal findings relative to baseline [Safety and Tolerability] 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)
Trial Locations
- Locations (1)
TomskNRMC
🇷🇺Tomsk, Russian Federation