NCT05940298CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 26 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 4 Jul 2023
- Start date
- Jul 2023
- Primary completion date
- Jun 2024
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Diseases
- Prostate cancer
- NCT number
- NCT05940298
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 10
- From Jul 2023 to the primary completion date, Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening)
- Ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's
Other illness
- Active current autoimmune disease or history of autoimmune disease
- Known HIV positive or chronically active hepatitis B or C
Other
- Administration of other investigational medicinal product within 30 days of screening
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| TomskNRMC Coordinator of this site? Confirm its status | Tomsk | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.