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

Hodgkin Lymphoma, Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04292626
• Other study ID #: Lymphoma-Tc-99m
• Status: Completed
• Phase: Phase 1
• Start date: January 19, 2020
• Est. completion date: March 19, 2021

Study information

• Verified date: February 2020
• Source: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 19, 2021
• Est. primary completion date: February 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	TomskNRMC	Tomsk

Sponsors (2)

Lead Sponsor	Collaborator
Tomsk National Research Medical Center of the Russian Academy of Sciences	Uppsala University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 hours
Primary	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	6 hours
Primary	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	6 hours
Primary	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)	6 hours
Secondary	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)	24 hours
Secondary	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)	24 hours
Secondary	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)	24 hours
Secondary	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.	24 hours