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

• Status: Completed
• Trial end date: 2021-02-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

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

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