Prostate CancerPhase 1NCT05940298
Molecular Imaging of Gastrin Releasing Peptide Receptors Using Labeled Technetium-99m DB8
A Phase 1 study testing Intravenous injection of [99mTc]Tc-DB8 in people with Prostate Cancer and Breast Cancer, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Prostate Cancer, Breast Cancer
- What is being tested?
- Intravenous injection of [99mTc]Tc-DB8
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteRussia
- Study dates
- 3 Jul 2023to 31 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- To assess the distribution of [99mTc]Tc- DB8 in normal tissues and tumors at different time intervals.
- To evaluate dosimetry of [99mTc]Tc- DB8.
- To study the safety and tolerability of the drug [99mTc]Tc- DB8 after a single injection in a diagnostic dosage.
The secondary objective are:
- 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.
Read the 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:
- To evaluate the distribution of 99mTc-DB8 in normal tissues and tumors in patients with prostate cancer and breast cancer at different time intervals.
- To evaluate dosimetry of 99mTc-DB8 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-DB8 after a single intravenous administration in a diagnostic dosage.
Additional research tasks:
- 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
- Being tested
- Intravenous injection of [99mTc]Tc-DB8
- Keywords
- Prostate cancer, Breast cancer, Gastrin releasing peptide receptors, [99mTc]Tc-DB8, SPECT
- Medical subject headings
- Prostatic Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous injection of [99mTc]Tc-DB8Drug
Also called [99mTc]Tc-DB8
One single intravenous injection of [99mTc]Tc-DB8, followed by gamma camera imaging after 2, 4, 6 and 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Prostate cancer | Experimental | At least five (5) evaluable subjects with prostate cancer Receives: Drug: Intravenous injection of [99mTc]Tc-DB8 |
| Breast cancer | Experimental | At least five (5) evaluable subjects with breast cancer Receives: Drug: Intravenous injection of [99mTc]Tc-DB8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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)
Measured: 6 hours
Secondary outcomes (4)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start3 Jul 2023
- Primary completion1 Jun 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University
- Responsible party
- Sponsor
- Investigators
- Vladimir I Chernov, MD,Prof, Principal investigator, TomskNRMC Tomsk, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940298
- Sponsor's protocol ID
- ORI-07/3
- Status last verified
- Jun 2026
- First submitted
- 4 Jul 2023
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPECT Imaging of Gastrin Releasing Peptide Receptors Using Labeled Technetium-99m DB8 ([99mTc]Tc- DB8) in Prostate Cancer and Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05940298
- Acronym / sponsor ID
- ORI-07/3
- Conditions
- Prostate Cancer, Breast Cancer
- Keywords
- Prostate cancer, Breast cancer, Gastrin releasing peptide receptors, [99mTc]Tc-DB8, SPECT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Collaborators
- Uppsala University
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study should evaluate the biological distribution of 99mTc-DB8 in patients with prostate cancer and breast cancer.
The primary objective are:
- To assess the distribution of [99mTc]Tc- DB8 in normal tissues and tumors at different time intervals.
- To evaluate dosimetry of [99mTc]Tc- DB8.
- To study the safety and tolerability of the drug [99mTc]Tc- DB8 after a single injection in a diagnostic dosage.
The secondary objective are:
- 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:
- To evaluate the distribution of 99mTc-DB8 in normal tissues and tumors in patients with prostate cancer and breast cancer at different time intervals.
- To evaluate dosimetry of 99mTc-DB8 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-DB8 after a single intravenous administration in a diagnostic dosage.
Additional research tasks:
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Prostate cancer | Experimental | Drug: Intravenous injection of [99mTc]Tc-DB8At least five (5) evaluable subjects with prostate cancer |
| Breast cancer | Experimental | Drug: Intravenous injection of [99mTc]Tc-DB8At least five (5) evaluable subjects with breast cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous injection of [99mTc]Tc-DB8Also: [99mTc]Tc-DB8One single intravenous injection of [99mTc]Tc-DB8, followed by gamma camera imaging after 2, 4, 6 and 24 hours. | Drug | Breast cancer, Prostate cancer |
Primary outcome
Gamma camera-based whole-body [99mTc]Tc-DB8 uptake value (%)
Time frame: 24 hours
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
SPECT-based [99mTc]Tc-DB8 value in tumor lesions (counts)
Time frame: 6 hours
[99mTc]Tc-DB8 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts
SPECT-based [99mTc]Tc-DB8 background uptake value (counts)
Time frame: 6 hours
Focal uptake of [99mTc]Tc-DB8 in the regions without pathological findings will be assessed with SPECT and measured in counts
Tumor-to-background ratio (SPECT)
Time frame: 6 hours
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)
4 secondary outcomes
Safety attributable to [99mTc]Tc-DB8 injections (physical findings)
Time frame: 24 hours
Safety attributable to [99mTc]Tc-DB8 injections (laboratory tests)
Time frame: 24 hors
Safety attributable to [99mTc]Tc-DB8 injections (incidence of adverse events)
Time frame: 24 hours
Safety attributable to [99mTc]Tc-DB8 injections (concomitant medication)
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir I Chernov, MD,Prof principal investigator
TomskNRMC Tomsk, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intravenous injection of [99mTc]Tc-DB8 in people with Prostate Cancer and Breast Cancer, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gamma camera-based whole-body [99mTc]Tc-DB8 uptake value (%) (time frame: 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.