Molecular Imaging of Brain Tumors Using Labeled Technetium-99m 1-Thio-D-Glucose.

NCT ID: NCT04288518

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-15
• Study Completion Date: 2021-02-15

Brief Summary

The study should evaluate the biological distribution of 99mTc-1-thio-D-glucose in patients with primary brain tumors and recurrence of brain tumors.

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 SPECT imaging results of brain tumors with the data of magnetic resonance imaging (MRI) and/or positron emission tomography (PET) and immunohistochemical (IHC) studies of postoperative material.

Detailed Description

The overall goal is to study the effectiveness of SPECT imaging of primary brain tumors and relapse of brain tumors using technetium-99m labeled glucose.

Phase I of the study:

Biodistribution of 99mTc-1-thio-D-glucose in patients with primary brain tumors and in patients with recurrence of a brain tumor.

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 brain tumors at different time intervals.

2. To evaluate dosimetry 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 brain tumors by SPECT using 99mTc-1-thio-D-glucose with data obtained by magnetic resonance imaging (MRI) and/or positron emission tomography (PET) and immunohistochemical (IHC) research of postoperative material.

2. To study the diagnostic effectiveness of 99mTc-1-thio-D-glucose SPECT in imaging of brain tumors.

3. To evaluate the overall survival of patients with brain tumors depending on the results of 99mTc-1-thio-D-glucose SPECT.

Methodology:

Open-label, exploratory, single centre study. The subjects will receive a single injection of the labelled tracer.

Conditions

Brain; Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Primary Brain Tumor

The tested injected doses of 99mTc-1-thio-D-glucose 500 megabecquerels (MBq).

At least five (5) evaluable subjects with primary brain tumor. The tested injected dose 500 MBq.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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.

Recurrence of Brain Tumor

The tested injected doses of 99mTc-1-thio-D-glucose 500 MBq.

At least five (5) evaluable subjects with recurrence of brain tumor. The tested injected dose 500 MBq

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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.

Benign intracranial lesions

The tested injected doses of 99mTc-1-thio-D-glucose 500 MBq.

At least five (5) evaluable subjects with benign intracranial lesions. The tested injected dose 500 MBq

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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.

Interventions

SPECT or SPECT-CT 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.

Intervention Type: DRUG

Other Intervention Names

99mTc-1-thio-D-glucose

Eligibility Criteria

Inclusion Criteria

• Subject is > 18 years of age
• Clinical and radiological diagnosis of a primary brain tumor or recurrence of a brain tumor with immunohistological verification.
• Clinical and radiological diagnosis of a benign intracranial lesions.
• White blood cell count: > 2.0 x 10^9/L
• Haemoglobin: > 80 g/L
• Platelets: > 50.0 x 10^9/L
• alanine amino transferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (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

• Second, non-brain malignancy
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: collaborator

Tomsk National Research Medical Center of the Russian Academy of Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vladimr I Chernov

Role: PRINCIPAL_INVESTIGATOR

Tomsk NRMC

Locations

TomskNRMC

Tomsk, , Russia

Countries

Russia

Other Identifiers

Imaging of brain tumors

Identifier Type: -

Identifier Source: org_study_id