Clinical trial NCT04288518: Molecular Imaging of Brain Tumors Using Labeled Technetium-99m 1-Thio-D-Glucose.
Official title: SPECT Imaging of Brain Tumors Using Technetium-99m Labeled 1-Thio-D-Glucose (99mTc-1-thio-D-glucose).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Brain
Neoplasms
Keywords: 99mTc-1-thio-D-glucose
Brain
Neoplasms
SPECT
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sponsor class: OTHER
Collaborators: name: Uppsala University
First posted: 2020-02-28
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Gamma camera-based whole-body 99mTc-1-thio-D-glucose uptake value (percent)
timeFrame: 24 hours
measure: SPECT-based 99mTc-1-thio-D-glucose value in tumor lesions (counts)
timeFrame: 6 hours
measure: SPECT-based 99mTc-1-thio-D-glucose uptake value (counts)
timeFrame: 6 hours
measure: Tumor-to-background ratio (unitless value)
timeFrame: 6 hours
Secondary outcomes:
measure: Safety attributable to 99mTc-1-thio-D-glucose injections, based on the rate of abnormal physical findings (percent)
timeFrame: 24 hours
measure: Safety attributable to 99mTc-1-thio-D-glucose injections, based on the rate of abnormal laboratory results (percent)
timeFrame: 24 hours
measure: Safety attributable to 99mTc-1-thio-D-glucose injections, based on the rate of adverse events (percent)
timeFrame: 24 hours
measure: Safety attributable to 99mTc-1-thio-D-glucose injections, based on the need for concomitant medication (percent)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Tomsk
country: Russian Federation
facility: TomskNRMC
Study officials:
affiliation: Tomsk NRMC
name: Vladimr I Chernov
role: PRINCIPAL_INVESTIGATOR
References: