Status:
COMPLETED
Molecular Imaging of Brain Tumors Using Labeled Technetium-99m 1-Thio-D-Glucose.
Lead Sponsor:
Tomsk National Research Medical Center of the Russian Academy of Sciences
Collaborating Sponsors:
Uppsala University
Conditions:
Brain
Neoplasms
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
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 dist...
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 99m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04288518
Start Date
February 15 2020
End Date
February 15 2021
Last Update
October 23 2023
Active Locations (1)
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1
TomskNRMC
Tomsk, Russia