Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT06101927
Status:
COMPLETED
Last Update Posted:
2025-04-09
First Post:
2023-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Molecular Imaging of Prostate-Specific Membrane Antigen Using Labeled Technetium-99m BQ0413
Sponsor:
Tomsk National Research Medical Center of the Russian Academy of Sciences
Organization:
Study Overview
Official Title:
SPECT Imaging of Prostate-Specific Membrane Antigen Using Labeled Technetium-99m BQ0413 ([99mTc]Tc- BQ0413) in Prostate Cancer Patients
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: