99mTc-1-thio-D-glucose SPECT/CT Versus 18F-Fluoroethyl-l-tyrosine PET/CT in Brain Tumor Imaging

Tomsk National Research Medical Center of the Russian Academy of Sciences

Status: Active, not recruiting

Conditions: Glioma (Any Grade) in the Brain

Treatments: Drug: 18F-FET; Drug: 99mTc-1-thio-D-glucose

Study type: Interventional

Funder types: Other

Identifiers

NCT07475390

99mTc-thio-glucose vs 18F-FET

Details and patient eligibility

About

An open-label, single-center study with 99mTc-1-thio-D-glucose single photon emission computed tomography / computed tomography (SPECT/CT) and 18F-fluoroethyl-l-tyrosine (18F-FET) positron emission tomography / computed tomography (PET/CT) in primary and recurrent glioma patients, where the primary endpoint of the study is to compare imaging properties of 99mTc-1-thio-D-glucose SPECT/CT and 18F-FET PET/CT of brain tumor Imaging.

Full description

The primary objectives are:

- To compare 99mTc-1-thio-D-glucose SPECT/CT and 18F-FET PET/CT properties in primary and recurrent glioma patients

The secondary objectives are:

- To compare the accumulation levels of 99mTc-1-thio-D-glucose and 18F-FET depending on the pathomorphological (biopsy/surgical material) and molecular genetic (Ki-67, isocitrate dehydrogenase 1/2 (IDH1/2) mutations, p53 expression) characteristics of the tumor.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of primary and recurrent glioma;

• Sequential injection of 99mTc-1-thio-D-glucose and 18F-FET in the interval of 14 days in each patient;

• Hematological, liver and renal function test results within the following limits:

  • White blood cell count: > 2.0 x 109/L
  • Hemoglobin: > 80 g/L
  • Platelets: > 50.0 x 109/L
  • Alanine aminotransferase (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

• A negative pregnancy test 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Primary and recurrent glioma patients.

Experimental group

Description:

Maximum (40) evaluable subjects with primary and recurrent glioma have to be enrolled in the study. Subjects withdrawn from the study for any reason will be replaced

Treatment:

Drug: 99mTc-1-thio-D-glucose

Drug: 18F-FET