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

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT04292626

Collaborator

Uppsala University (Other)

Enrollment

Location

Arm

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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:

To assess the distribution of 99mTc-1-thio-D-glucose in normal tissues and tumors at different time intervals.
To evaluate dosimetry of 99mTc-1-thio-D-glucose.
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:

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.

Condition or Disease	Intervention/Treatment	Phase
Hodgkin Lymphoma, Adult Non-Hodgkin Lymphoma, Adult	Diagnostic Test: SPECT with 99mTc-1-thio-D-glucose	Phase 1

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:

To evaluate the distribution of 99mTc-1-thio-D-glucose in normal tissues and tumors in patients with Lymphoma at different time intervals.
To evaluate dosimetry of 99mTc-1-thio-D-glucose based on the pharmacokinetic parameters of the drug after a single intravenous administration.
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:

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

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jan 19, 2020

Actual Primary Completion Date :

Feb 19, 2021

Actual Study Completion Date :

Mar 19, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lymphoma At least five (5) evaluable subjects with Hodgkin Lymphoma or Non Hodgkin Lymphoma. The tested injected dose of 500 MBq.	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.

Arm

Intervention/Treatment

Experimental: Lymphoma

At least five (5) evaluable subjects with Hodgkin Lymphoma or Non Hodgkin Lymphoma. The tested injected dose of 500 MBq.

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.

Outcome Measures

Primary Outcome Measures

Gamma camera-based whole-body 99mTc-1-thio-D-glucose uptake value (percent) [24 hours]
Whole-body 99mTc-1-thio-D-glucose uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (percent) of the injected dose of the radiopharmaceutical
SPECT-based 99mTc-1-thio-D-glucose value in tumor lesions (counts) [6 hours]
99mTc-1-thio-D-glucose uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts
SPECT-based 99mTc-1-thio-D-glucose uptake value (counts) [6 hours]
Focal uptake of 99mTc-1-thio-D-glucose in the regions without pathological findings will be assessed with SPECT and measured in counts
Tumor-to-background ratio (SPECT) [6 hours]
The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-1-thio-D-glucose uptake coinciding with tumor lesions (counts) will be divided by the value of 99mTc-1-thio-D-glucose uptake coinciding with the regions without pathological findings (counts)

Secondary Outcome Measures

Safety attributable to 99mTc-1-thio-D-glucose injections (physical findings) [24 hours]
The safety attributable to 99mTc-1-thio-D-glucose injections will be evaluated based on the assessments of physical examination, vital signs, and ECG (percent of cases with abnormal findings relative to baseline)
Safety attributable to 99mTc-1-thio-D-glucose injections (laboratory tests) [24 hours]
The safety attributable to 99mTc-1-thio-D-glucose injections will be evaluated based on the blood and urine laboratory tests (percent of cases with abnormal findings relative to baseline)
Safety attributable to 99mTc-1-thio-D-glucose injections (incidence and severity of adverse events) [24 hours]
The safety attributable to 99mTc-1-thio-D-glucose injections will be evaluated based on the rate of adverse events (percent)
Safety attributable to 99mTc-1-thio-D-glucose injections [24 hours]
Percent of participants with treatment-related adverse events requiring drug treatment will be used to assess the safety attributable to 99mTc-1-thio-D-glucose injections.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject is > 18 years of age
Clinical and radiological diagnosis of Hodgkin Lymphoma and Non Hodgkin Lymphoma with immunohistological verification.
White blood cell count: > 2.0 x 10^9/L
Haemoglobin: > 80 g/L
Platelets: > 50.0 x 10^9/L
ALT, ALP, AST: =< 5.0 times Upper Limit of Normal
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