NCT05940298

Molecular Imaging of Gastrin Releasing Peptide Receptors Using Labeled Technetium-99m DB8

SPECT Imaging of Gastrin Releasing Peptide Receptors Using Labeled Technetium-99m DB8 ([99mTc]Tc- DB8) in Prostate Cancer and Breast Cancer Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study should evaluate the biological distribution of 99mTc-DB8 in patients with prostate cancer and breast cancer. The primary objective are: 1. To assess the distribution of \[99mTc\]Tc- DB8 in normal tissues and tumors at different time intervals. 2. To evaluate dosimetry of \[99mTc\]Tc- DB8. 3. To study the safety and tolerability of the drug \[99mTc\]Tc- DB8 after a single injection in a diagnostic dosage. The secondary objective are: 1\. To compare the obtained \[99mTc\]Tc- DB8 SPECT imaging results with the data of CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) studies in prostate cancer and breast cancer patients.

Detailed description

The overall goal is to study the effectiveness of SPECT imaging prostate cancer and breast cancer patients Using technetium-99m labeled DB8. Phase I of the study: Biodistribution of 99mTc-DB8 in patients with prostate cancer and breast cancer. The main objectives of the study: 1. To evaluate the distribution of 99mTc-DB8 in normal tissues and tumors in patients with prostate cancer and breast cancer at different time intervals. 2. To evaluate dosimetry of 99mTc-DB8 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-DB8 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 and breast cancer by SPECT using 99mTc-DB8 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.

Conditions

• Prostate Cancer
• Breast Cancer

Interventions

Type	Name	Description
DRUG	Intravenous injection of [99mTc]Tc-DB8	One single intravenous injection of \[99mTc\]Tc-DB8, followed by gamma camera imaging after 2, 4, 6 and 24 hours.

Timeline

• Start date: 2023-07-03
• Primary completion: 2024-06-01
• Completion: 2024-12-31
• First posted: 2023-07-11
• Last updated: 2025-04-09

Locations

1 site across 1 country: Russia