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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Prostate Cancer
• Intervention / Treatment: Drug: Intravenous injection of [99mTc]Tc-DB8

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Russian Federation
  • Tomsk, Russian Federation
    • TomskNRMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prostate cancer; At least five (5) evaluable subjects with prostate cancer	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.; Other Names: [99mTc]Tc-DB8
Experimental: Breast cancer; At least five (5) evaluable subjects with breast cancer	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.; Other Names: [99mTc]Tc-DB8

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gamma camera-based whole-body [99mTc]Tc-DB8 uptake value (%)	Whole-body [99mTc]Tc-DB8 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]Tc-DB8 value in tumor lesions (counts)	[99mTc]Tc-DB8 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts	6 hours
SPECT-based [99mTc]Tc-DB8 background uptake value (counts)	Focal uptake of [99mTc]Tc-DB8 in the regions without pathological findings will be assessed with SPECT and measured in counts	6 hours
Tumor-to-background ratio (SPECT)	The SPECT-based tumor-to-background ratio will be calculated as follows: the value of [99mTc]Tc-DB8 uptake coinciding with tumor lesions (counts) will be divided by the value of [99mTc]Tc-DB8 uptake coinciding with the regions without pathological findings (counts)	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety attributable to [99mTc]Tc-DB8 injections (physical findings)	The safety attributable to [99mTc]Tc-DB8 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]Tc-DB8 injections (laboratory tests)	The safety attributable to [99mTc]Tc-DB8 injections will be evaluated based on the blood and urine laboratory tests (percent of cases with abnormal findings relative to baseline).	24 hors
Safety attributable to [99mTc]Tc-DB8 injections (incidence of adverse events)	The safety attributable to [99mTc]Tc-DB8 injections will be evaluated based on the rate of adverse events (percent).	24 hours
Safety attributable to [99mTc]Tc-DB8 injections (concomitant medication)	The safety attributable to [99mTc]Tc-DB8 injections will be evaluated based on the rate of administration of concomitant medication (percent).	24 hours

Collaborators and Investigators

• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Collaborators: Uppsala University
• Investigators: Principal Investigator: Vladimir I Chernov, MD,Prof, TomskNRMC Tomsk, Russia

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2023
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: July 4, 2023
• First Submitted That Met QC Criteria: July 4, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Breast cancer; Prostate cancer; SPECT; Gastrin releasing peptide receptors; [99mTc]Tc-DB8
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Skin Diseases; Breast Diseases; Prostatic Neoplasms; Breast Neoplasms
• Other Study ID Numbers: [99mTc]Tc- DB8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No