Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
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.
Study:
NCT06101927
Study Brief:
Protocol Section:
NCT06101927