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

Primary Purpose

Prostate Cancer, Breast Cancer Female

Status

Enrolling by invitation

Phase

Phase 1

Locations

Russian Federation

Study Type

Interventional

Intervention

whole body study and SPECT with 99mTc-RM26

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Gastrin releasing peptide receptors, Prostate cancer, Breast cancer, 99mTc-RM26, SPECT

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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
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

Sites / Locations

TomskNRMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Prostate cancer

Breast cancer

Arm Description

At least five (5) evaluable subjects with prostate cancer.

At least five (5) evaluable subjects breast cancer.

Outcomes

Primary Outcome Measures

Gamma camera-based whole-body 99mTc-RM26 uptake value (%)

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

SPECT-based 99mTc-RM26 value in tumor lesions (counts)

99mTc-RM26 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts

SPECT-based 99mTc-RM26 uptake value (counts)

Focal uptake of 99mTc-RM26 in the regions without pathological findings will be assessed with SPECT and measured in counts

Tumor-to-background ratio (SPECT)

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)

Secondary Outcome Measures

Safety attributable to 99mTc-RM26 injections (physical findings)

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)

Safety attributable to 99mTc-RM26 injections (laboratory tests)

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)

Safety attributable to 99mTc-RM26 injections (incidence and severity of adverse events)

The safety attributable to 99mTc-RM26 injections will be evaluated based on the rate of adverse events (percent)

Safety attributable to 99mTc-RM26 injections (concomitant medication)

The safety attributable to 99mTc-RM26 injections will be evaluated based on the rate of administration of concomitant medication (percent)

Full Information

NCT ID

NCT04746638

First Posted

February 3, 2021

Last Updated

July 4, 2022

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Collaborators

Uppsala University

1. Study Identification

Unique Protocol Identification Number

NCT04746638

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Enrolling by invitation

Study Start Date

February 1, 2021 (Actual)

Primary Completion Date

May 19, 2022 (Actual)

Study Completion Date

June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Collaborators

Uppsala University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The study should evaluate the biological distribution of 99mTc-RM26 in patients with prostate cancer and breast cancer. The primary objective are: To assess the distribution of 99mTc- RM26 in normal tissues and tumors at different time intervals. To evaluate dosimetry of 99mTc- RM26. 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer, Breast Cancer Female

Keywords

Gastrin releasing peptide receptors, Prostate cancer, Breast cancer, 99mTc-RM26, SPECT

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prostate cancer

Arm Type

Experimental

Arm Description

At least five (5) evaluable subjects with prostate cancer.

Arm Title

Breast cancer

Arm Type

Experimental

Arm Description

At least five (5) evaluable subjects breast cancer.

Intervention Type

Diagnostic Test

Intervention Name(s)

whole body study and SPECT with 99mTc-RM26

Intervention Description

One single intravenous injection of 99mTc-RM26, followed by gamma camera imaging after 2, 4, 6 and 24 hours.

Primary Outcome Measure Information:

Title

Gamma camera-based whole-body 99mTc-RM26 uptake value (%)

Description

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

Time Frame

24 hours

Title

SPECT-based 99mTc-RM26 value in tumor lesions (counts)

Description

99mTc-RM26 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts

Time Frame

6 hours

Title

SPECT-based 99mTc-RM26 uptake value (counts)

Description

Focal uptake of 99mTc-RM26 in the regions without pathological findings will be assessed with SPECT and measured in counts

Time Frame

6 hours

Title

Tumor-to-background ratio (SPECT)

Description

Time Frame

6 hours

Secondary Outcome Measure Information:

Title

Safety attributable to 99mTc-RM26 injections (physical findings)

Description

Time Frame

24 hours

Title

Safety attributable to 99mTc-RM26 injections (laboratory tests)

Description

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)

Time Frame

24 hours

Title

Safety attributable to 99mTc-RM26 injections (incidence and severity of adverse events)

Description

The safety attributable to 99mTc-RM26 injections will be evaluated based on the rate of adverse events (percent)

Time Frame

24 hours

Title

Safety attributable to 99mTc-RM26 injections (concomitant medication)

Description

The safety attributable to 99mTc-RM26 injections will be evaluated based on the rate of administration of concomitant medication (percent)

Time Frame

24 hours

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

Men for prostate cancer and women for breast cancer

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vladimir I Chernov, MD,PhD

Organizational Affiliation

Tomsk NRMC

Official's Role

Principal Investigator

Facility Information:

Facility Name

TomskNRMC

City

Tomsk

Country

Russian Federation

12. IPD Sharing Statement

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

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