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Molecular Imaging of Gastrin Releasing Peptide Receptors Using Labeled Technetium-99m RM26

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ClinicalTrials.gov Identifier: NCT04746638
Recruitment Status : Enrolling by invitation
First Posted : February 10, 2021
Last Update Posted : February 10, 2021
Sponsor:
Collaborator:
Uppsala University
Information provided by (Responsible Party):
Tomsk National Research Medical Center of the Russian Academy of Sciences

Brief Summary:

The study should evaluate the biological distribution of 99mTc-RM26 in patients with prostate cancer and breast cancer.

The primary objective are:

  1. To assess the distribution of 99mTc- RM26 in normal tissues and tumors at different time intervals.
  2. To evaluate dosimetry of 99mTc- RM26.
  3. To study the safety and tolerability of the drug 99mTc- RM26 after a single injection in a diagnostic dosage.

The secondary objective are:

1. To compare the obtained 99mTc- RM26 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 Female Diagnostic Test: whole body study and SPECT with 99mTc-RM26 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 RM26.

Phase I of the study:

Biodistribution of 99mTc-RM26 in patients with prostate cancer and breast cancer.

The main objectives of the study:

  1. To evaluate the distribution of 99mTc-RM26 in normal tissues and tumors in patients with prostate cancer and breast cancer at different time intervals.
  2. To evaluate dosimetry of 99mTc-RM26 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-RM26 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-RM26 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: SPECT Imaging of Gastrin Releasing Peptide Receptors Using Labeled Technetium-99m RM26 (99mTc- RM26) in Prostate Cancer and Breast Cancer Patients
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prostate cancer
At least five (5) evaluable subjects with prostate cancer.
Diagnostic Test: whole body study and SPECT with 99mTc-RM26
One single intravenous injection of 99mTc-RM26, followed by gamma camera imaging after 2, 4, 6 and 24 hours.

Experimental: Breast cancer
At least five (5) evaluable subjects breast cancer.
Diagnostic Test: whole body study and SPECT with 99mTc-RM26
One single intravenous injection of 99mTc-RM26, followed by gamma camera imaging after 2, 4, 6 and 24 hours.




Primary Outcome Measures :
  1. Gamma camera-based whole-body 99mTc-RM26 uptake value (%) [ Time Frame: 24 hours ]
    Whole-body 99mTc-RM26 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-RM26 value in tumor lesions (counts) [ Time Frame: 6 hours ]
    99mTc-RM26 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts

  3. SPECT-based 99mTc-RM26 uptake value (counts) [ Time Frame: 6 hours ]
    Focal uptake of 99mTc-RM26 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-RM26 uptake coinciding with tumor lesions (counts) will be divided by the value of 99mTc-RM26 uptake coinciding with the regions without pathological findings (counts)


Secondary Outcome Measures :
  1. Safety attributable to 99mTc-RM26 injections (physical findings) [ Time Frame: 24 hours ]
    The safety attributable to 99mTc-RM26 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-RM26 injections (laboratory tests) [ Time Frame: 24 hours ]
    The safety attributable to 99mTc-RM26 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-RM26 injections (incidence and severity of adverse events) [ Time Frame: 24 hours ]
    The safety attributable to 99mTc-RM26 injections will be evaluated based on the rate of adverse events (percent)

  4. Safety attributable to 99mTc-RM26 injections (concomitant medication) [ Time Frame: 24 hours ]
    The safety attributable to 99mTc-RM26 injections will be evaluated based on the rate of administration of concomitant medication (percent)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Men for prostate cancer and women for breast cancer
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

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): NCT04746638


Locations
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Russian Federation
TomskNRMC
Tomsk, Russian Federation
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,PhD Tomsk NRMC
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Responsible Party: Tomsk National Research Medical Center of the Russian Academy of Sciences
ClinicalTrials.gov Identifier: NCT04746638    
Other Study ID Numbers: 99mTc- RM26
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021

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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:
Gastrin releasing peptide receptors
Prostate cancer
Breast cancer
99mTc-RM26
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
Prostatic Diseases