Molecular Imaging of Gastrin Releasing Peptide Receptors Using Labeled Technetium-99m RM26
NCT ID: NCT04746638
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2021-02-01
2023-06-01
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Prostate cancer
At least five (5) evaluable subjects with prostate cancer.
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.
Breast cancer
At least five (5) evaluable subjects breast cancer.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
70 Years
ALL
No
Sponsors
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Uppsala University
OTHER
Tomsk National Research Medical Center of the Russian Academy of Sciences
OTHER
Responsible Party
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Principal Investigators
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Vladimir I Chernov, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Tomsk NRMC
Locations
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TomskNRMC
Tomsk, , Russia
Countries
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Other Identifiers
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99mTc- RM26
Identifier Type: -
Identifier Source: org_study_id