Molecular Imaging of Lymphoma Using Labeled Technetium-99m

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04292626
Study type	Interventional
Source	Tomsk National Research Medical Center of the Russian Academy of Sciences
Contact
Status	Completed
Phase	Phase 1
Start date	January 19, 2020
Completion date	March 19, 2021

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms