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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06101927
• Other study ID #: [99mTc]Tc- BQ0413
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: October 19, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: October 2023
• Source: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: October 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Whole body study and SPECT with [99mTc]Tc-BQ0413
One single intravenous injection of [99mTc]Tc-BQ0413, followed by gamma camera imaging after 2, 4, 6 and 24 hours.

Locations

Country	Name	City	State
Russian Federation	TomskNRMC	Tomsk

Sponsors (2)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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