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

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ClinicalTrials.gov Identifier: NCT05940298
Recruitment Status : Recruiting
First Posted : July 11, 2023
Last Update Posted : April 26, 2024
Sponsor:
Collaborator:
Uppsala University
Information provided by (Responsible Party):
Tomsk National Research Medical Center of the Russian Academy of Sciences

Study Description
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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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Breast Cancer Drug: Intravenous injection of [99mTc]Tc-DB8 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Single (Participant)
Masking Description: Single (Participant)
Primary Purpose: Diagnostic
Official Title: SPECT Imaging of Gastrin Releasing Peptide Receptors Using Labeled Technetium-99m DB8 ([99mTc]Tc- DB8) in Prostate Cancer and Breast Cancer Patients
Actual Study Start Date : July 3, 2023
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : July 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: [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 Name: [99mTc]Tc-DB8


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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)


Secondary Outcome Measures :
  1. Safety attributable to [99mTc]Tc-DB8 injections (physical findings) [ Time Frame: 24 hours ]
    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).

  2. Safety attributable to [99mTc]Tc-DB8 injections (laboratory tests) [ Time Frame: 24 hors ]
    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).

  3. Safety attributable to [99mTc]Tc-DB8 injections (incidence of adverse events) [ Time Frame: 24 hours ]
    The safety attributable to [99mTc]Tc-DB8 injections will be evaluated based on the rate of adverse events (percent).

  4. Safety attributable to [99mTc]Tc-DB8 injections (concomitant medication) [ Time Frame: 24 hours ]
    The safety attributable to [99mTc]Tc-DB8 injections will be evaluated based on the rate of administration of concomitant medication (percent).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05940298


Contacts
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Contact: Vladimir I Chernov, MD,Prof +73822426284 chernov@tnimc.ru
Contact: Anastasiy N Rybina, MD,PhD +73822426284 pankovaan@mail.ru

Locations
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Russian Federation
TomskNRMC Recruiting
Tomsk, Russian Federation
Contact: Vladimir I Chernov, MD, Prof.    +7-3822-426284    chernov@tnimc.ru   
Sponsors and Collaborators
Tomsk National Research Medical Center of the Russian Academy of Sciences
Uppsala University
Investigators
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Principal Investigator: Vladimir I Chernov, MD,Prof TomskNRMC Tomsk, Russia
More Information
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Responsible Party: Tomsk National Research Medical Center of the Russian Academy of Sciences
ClinicalTrials.gov Identifier: NCT05940298    
Other Study ID Numbers: [99mTc]Tc- DB8
First Posted: July 11, 2023    Key Record Dates
Last Update Posted: April 26, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tomsk National Research Medical Center of the Russian Academy of Sciences:
Prostate cancer
Breast cancer
Gastrin releasing peptide receptors
[99mTc]Tc-DB8
SPECT
Additional relevant MeSH terms:
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Breast Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
 Urogenital Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases