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Spots Global Cancer Trial Database for Molecular Imaging of Lymphoma Using Labeled Technetium-99m 1-Thio-D-Glucose

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Trial Identification

Brief Title: Molecular Imaging of Lymphoma Using Labeled Technetium-99m 1-Thio-D-Glucose

Official Title: SPECT Imaging of Lymphoma Using Technetium-99m Labeled 1-Thio-D-Glucose (99mTc-1-thio-D-glucose)

Study ID: NCT04292626

Study Description

Brief Summary: The study should evaluate the biological distribution of 99mTc-1-thio-D-glucose in patients with Hodgkin Lymphoma and Non Hodgkin Lymphoma. The primary objective are: 1. To assess the distribution of 99mTc-1-thio-D-glucose in normal tissues and tumors at different time intervals. 2. To evaluate dosimetry of 99mTc-1-thio-D-glucose. 3. To study the safety and tolerability of the drug 99mTc-1-thio-D-glucose after a single injection in a diagnostic dosage. The secondary objective are: 1. To compare the obtained 99mTc-1-thio-D-glucose SPECT imaging results with the data of CT imaging and/or 18F-FDG positron emission tomography (PET) and immunohistochemical (IHC) studies in Lymphoma patients.

Detailed Description: The overall goal is to study the effectiveness of SPECT imaging Hodgkin Lymphoma and Non Hodgkin Lymphoma Using technetium-99m labeled 1-thio-D-glucose. Phase I of the study: Biodistribution of 99mTc-1-thio-D-glucose in patients with Hodgkin Lymphoma and Non Hodgkin Lymphoma. The main objectives of the study: 1. To evaluate the distribution of 99mTc-1-thio-D-glucose in normal tissues and tumors in patients with Lymphoma at different time intervals. 2. To evaluate dosimetry of 99mTc-1-thio-D-glucose 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-1-thio-D-glucose 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 Lymphoma by SPECT using 99mTc-1-thio-D-glucose with data obtained by CT and/or positron emission tomography (PET) 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

TomskNRMC, Tomsk, , Russian Federation

Contact Details

Name: Vladimir I Chernov, MD, PhD

Affiliation: Tomsk NRMC

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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