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

NCT05940298 | Completed Phase 1

• 1 other identifier: [99mTc]Tc- DB8
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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. 1.To assess the distribution of \[99mTc\]Tc- DB8 in normal tissues and tumors at different time intervals.
2. 2.To evaluate dosimetry of \[99mTc\]Tc- DB8.
3. 3.To study the safety and tolerability of the drug \[99mTc\]Tc- DB8 after a single injection in a diagnostic dosage.

Conditions

Prostate Cancer; Breast Cancer

Keywords

Prostate cancer; Breast cancer; Gastrin releasing peptide receptors; [99mTc]Tc-DB8; SPECT

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Safety attributable to [99mTc]Tc-DB8 injections (physical findings)

  24 hours

• Safety attributable to [99mTc]Tc-DB8 injections (laboratory tests)

  24 hors

• Safety attributable to [99mTc]Tc-DB8 injections (incidence of adverse events)

  24 hours

• Safety attributable to [99mTc]Tc-DB8 injections (concomitant medication)

  24 hours

Study Arms (2)

Prostate cancer

EXPERIMENTAL

At least five (5) evaluable subjects with prostate cancer

Drug: Intravenous injection of [99mTc]Tc-DB8

Breast cancer

EXPERIMENTAL

At least five (5) evaluable subjects with breast cancer

Drug: Intravenous injection of [99mTc]Tc-DB8

Interventions

Intravenous injection of [99mTc]Tc-DB8 DRUG

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

Also known as: [99mTc]Tc-DB8

Breast cancer; Prostate cancer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead
• Uppsala University: collaborator

Study Sites (1)

TomskNRMC

Tomsk, Russia

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Vladimir I Chernov, MD,Prof

  TomskNRMC Tomsk, Russia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participant)
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 11, 2023
• Study Start: July 3, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 31, 2024
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)