NCT04292626

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hodgkin Lymphoma, Adult
• Non-Hodgkin Lymphoma, Adult

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	SPECT with 99mTc-1-thio-D-glucose	One single intravenous injection of 99mTc-1-thio-D-glucose, followed by gamma camera imaging directly postinjection and after 2, 4, 6 and 24 hours.

Timeline

• Start date: 2020-01-19
• Primary completion: 2021-02-19
• Completion: 2021-03-19
• First posted: 2020-03-03
• Last updated: 2021-04-01

Locations

1 site across 1 country: Russia