Recruitment

Recruitment Status
Enrolling by invitation
Estimated Enrollment
Same as current

Summary

Conditions
  • Breast Cancer - Female
  • Prostate Cancer
Type
Interventional
Phase
Phase 1
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Primary Purpose: Diagnostic

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

Description

The overall goal is to study the effectiveness of SPECT imaging prostate cancer and breast cancer patients Using technetium-99m labeled RM26. Phase I of the study: Biodistribution of 99mTc-RM26 in patients with prostate cancer and breast cancer. The main objectives of the study: To evaluate the dist...

The overall goal is to study the effectiveness of SPECT imaging prostate cancer and breast cancer patients Using technetium-99m labeled RM26. Phase I of the study: Biodistribution of 99mTc-RM26 in patients with prostate cancer and breast cancer. The main objectives of the study: To evaluate the distribution of 99mTc-RM26 in normal tissues and tumors in patients with prostate cancer and breast cancer at different time intervals. To evaluate dosimetry of 99mTc-RM26 based on the pharmacokinetic parameters of the drug after a single intravenous administration. To study the safety of use and tolerability of the drug 99mTc-RM26 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-RM26 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.

Tracking Information

NCT #
NCT04746638
Collaborators
Uppsala University
Investigators
Principal Investigator: Vladimir I Chernov, MD,PhD Tomsk NRMC