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COMPLETEDPHASE1

Molecular Imaging of Gastrin Releasing Peptide Receptors Using Labeled Technetium-99m RM26

SPECT Imaging of Gastrin Releasing Peptide Receptors Using Labeled Technetium-99m RM26 (99mTc- RM26) in Prostate Cancer and Breast Cancer Patients

NCT04746638•Tomsk National Research Medical Center of the Russian Academy of Sciences

View on ClinicalTrials.gov

Summary

The study should evaluate the biological distribution of 99mTc-RM26 in patients with prostate cancer and breast cancer. The primary objective are: 1. To assess the distribution of 99mTc- RM26 in normal tissues and tumors at different time intervals. 2. To evaluate dosimetry of 99mTc- RM26. 3. To study the safety and tolerability of the drug 99mTc- RM26 after a single injection in a diagnostic dosage. The secondary objective are: 1\. To compare the obtained 99mTc- RM26 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 RM26. Phase I of the study: Biodistribution of 99mTc-RM26 in patients with prostate cancer and breast cancer. The main objectives of the study: 1. To evaluate the distribution of 99mTc-RM26 in normal tissues and tumors in patients with prostate cancer and breast cancer at different time intervals. 2. To evaluate dosimetry of 99mTc-RM26 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-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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject is \> 18 years of age
•Clinical and radiological diagnosis of prostate cancer and breast 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
•A negative pregnancy test (serum beta-human chorionic gonadotropin, beta-HCG) at screening for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination
•Subject is capable to undergo the diagnostic investigations to be performed in the study
+1 more criteria

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

Locations (1)

TomskNRMC

Tomsk, Russia

Key Dates

Start Date

February 1, 2021

Primary Completion Date

May 19, 2022

Completion Date

June 1, 2023

Last Updated

November 28, 2023

Enrollment

ACTUAL participants

Conditions

Prostate CancerBreast Cancer Female

Interventions

whole body study and SPECT with 99mTc-RM26

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 28, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Molecular Imaging of Gastrin Releasing Peptide Receptors Using Labeled Technetium-99m RM26

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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