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

Primary Purpose

Hodgkin Lymphoma, Adult, Non-Hodgkin Lymphoma, Adult

Status

Completed

Phase

Phase 1

Locations

Russian Federation

Study Type

Interventional

Intervention

SPECT with 99mTc-1-thio-D-glucose

About this trial

This is an interventional diagnostic trial for Hodgkin Lymphoma, Adult focused on measuring Hodgkin Lymphoma, Non Hodgkin Lymphoma, 99mTc-1-thio-D-glucose, SPECT

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

TomskNRMC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lymphoma

Arm Description

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

Outcomes

Primary Outcome Measures

Gamma camera-based whole-body 99mTc-1-thio-D-glucose uptake value (percent)

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)

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)

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)

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)

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)

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)

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

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.

Full Information

NCT ID

NCT04292626

First Posted

February 20, 2020

Last Updated

March 30, 2021

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Collaborators

Uppsala University

1. Study Identification

Unique Protocol Identification Number

NCT04292626

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 Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

January 19, 2020 (Actual)

Primary Completion Date

February 19, 2021 (Actual)

Study Completion Date

March 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Collaborators

Uppsala University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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: 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: 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hodgkin Lymphoma, Adult, Non-Hodgkin Lymphoma, Adult

Keywords

Hodgkin Lymphoma, Non Hodgkin Lymphoma, 99mTc-1-thio-D-glucose, SPECT

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lymphoma

Arm Type

Experimental

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

SPECT with 99mTc-1-thio-D-glucose

Intervention Description

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.

Primary Outcome Measure Information:

Title

Gamma camera-based whole-body 99mTc-1-thio-D-glucose uptake value (percent)

Description

Time Frame

24 hours

Title

SPECT-based 99mTc-1-thio-D-glucose value in tumor lesions (counts)

Description

99mTc-1-thio-D-glucose uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts

Time Frame

6 hours

Title

SPECT-based 99mTc-1-thio-D-glucose uptake value (counts)

Description

Focal uptake of 99mTc-1-thio-D-glucose in the regions without pathological findings will be assessed with SPECT and measured in counts

Time Frame

6 hours

Title

Tumor-to-background ratio (SPECT)

Description

Time Frame

6 hours

Secondary Outcome Measure Information:

Title

Safety attributable to 99mTc-1-thio-D-glucose injections (physical findings)

Description

Time Frame

24 hours

Title

Safety attributable to 99mTc-1-thio-D-glucose injections (laboratory tests)

Description

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)

Time Frame

24 hours

Title

Safety attributable to 99mTc-1-thio-D-glucose injections (incidence and severity of adverse events)

Description

The safety attributable to 99mTc-1-thio-D-glucose injections will be evaluated based on the rate of adverse events (percent)

Time Frame

24 hours

Title

Safety attributable to 99mTc-1-thio-D-glucose injections

Description

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.

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vladimir I Chernov, MD, PhD

Organizational Affiliation

Tomsk NRMC

Official's Role

Principal Investigator

Facility Information:

Facility Name

TomskNRMC

City

Tomsk

Country

Russian Federation

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Deidentified individual participant data (text, tables, figures, and appendices), underlying the results of the trial, will be shared with researchers to achieve the aims in the approved proposal.

IPD Sharing Time Frame

Proposals may be submitted up to 36 months following publication of the results of the trial. After 36 months, the data will be available in the Center's data ware house but without investigator support other than deposited metadata.

IPD Sharing Access Criteria

Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.

Learn more about this trial

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

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