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

November 27, 2023 updated by: Tomsk National Research Medical Center of the Russian Academy of Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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
  • Informed consent

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prostate cancer
At least five (5) evaluable subjects with prostate cancer.
Diagnostic test: whole body study and SPECT with 99mTc-RM26
One single intravenous injection of 99mTc-RM26, followed by gamma camera imaging after 2, 4, 6 and 24 hours.
Experimental: Breast cancer
At least five (5) evaluable subjects breast cancer.
Diagnostic test: whole body study and SPECT with 99mTc-RM26
One single intravenous injection of 99mTc-RM26, followed by gamma camera imaging after 2, 4, 6 and 24 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gamma camera-based whole-body 99mTc-RM26 uptake value (%)
Time Frame: 24 hours
Whole-body 99mTc-RM26 uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical
24 hours
SPECT-based 99mTc-RM26 value in tumor lesions (counts)
Time Frame: 6 hours
99mTc-RM26 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts
6 hours
SPECT-based 99mTc-RM26 uptake value (counts)
Time Frame: 6 hours
Focal uptake of 99mTc-RM26 in the regions without pathological findings will be assessed with SPECT and measured in counts
6 hours
Tumor-to-background ratio (SPECT)
Time Frame: 6 hours
The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-RM26 uptake coinciding with tumor lesions (counts) will be divided by the value of 99mTc-RM26 uptake coinciding with the regions without pathological findings (counts)
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety attributable to 99mTc-RM26 injections (physical findings)
Time Frame: 24 hours
The safety attributable to 99mTc-RM26 injections will be evaluated based on the assessments of physical examination, vital signs, and ECG (percent of cases with abnormal findings relative to baseline)
24 hours
Safety attributable to 99mTc-RM26 injections (laboratory tests)
Time Frame: 24 hours
The safety attributable to 99mTc-RM26 injections will be evaluated based on the blood and urine laboratory tests (percent of cases with abnormal findings relative to baseline)
24 hours
Safety attributable to 99mTc-RM26 injections (incidence and severity of adverse events)
Time Frame: 24 hours
The safety attributable to 99mTc-RM26 injections will be evaluated based on the rate of adverse events (percent)
24 hours
Safety attributable to 99mTc-RM26 injections (concomitant medication)
Time Frame: 24 hours
The safety attributable to 99mTc-RM26 injections will be evaluated based on the rate of administration of concomitant medication (percent)
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Collaborators

Uppsala University

Investigators

  • Principal Investigator: Vladimir I Chernov, MD,PhD, Tomsk NRMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

May 19, 2022

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

February 3, 2021

First Submitted That Met QC Criteria

February 6, 2021

First Posted (Actual)

February 10, 2021

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 99mTc- RM26

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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