Molecular Imaging of Gastrin Releasing Peptide Receptors Using Labeled Technetium-99m DB8

NCT ID: NCT05940298

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-03
• Study Completion Date: 2024-12-31

Brief Summary

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.

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.

Conditions

Prostate Cancer; Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Prostate cancer

At least five (5) evaluable subjects with prostate cancer

Group Type: EXPERIMENTAL

Intravenous injection of [99mTc]Tc-DB8

Intervention Type: DRUG

One single intravenous injection of \[99mTc\]Tc-DB8, followed by gamma camera imaging after 2, 4, 6 and 24 hours.

Breast cancer

At least five (5) evaluable subjects with breast cancer

Group Type: EXPERIMENTAL

Intravenous injection of [99mTc]Tc-DB8

Intervention Type: DRUG

One single intravenous injection of \[99mTc\]Tc-DB8, followed by gamma camera imaging after 2, 4, 6 and 24 hours.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

[99mTc]Tc-DB8

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: collaborator

Tomsk National Research Medical Center of the Russian Academy of Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vladimir I Chernov, MD,Prof

Role: PRINCIPAL_INVESTIGATOR

TomskNRMC Tomsk, Russia

Locations

TomskNRMC

Tomsk, , Russia

Countries

Russia

Other Identifiers

[99mTc]Tc- DB8

Identifier Type: -

Identifier Source: org_study_id