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

• Status: Enrolling by invitation
• Trial end date: 2024-10-30
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Collaborator: Uppsala University

Criteria

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