68Ga-NOTA-Aca-BBN(7-14) PET/CT in Patients With Primary Gliomas

Study Overview
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Brief Summary
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This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-Aca-BBN(7-14) in glioma patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-Aca-BBN(7-14) will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.

Detailed Description
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Non-invasive imaging evaluation of GRPR expression would be of great help in drug development, patient stratification and therapeutic response monitoring. Various GRPR targeting imaging probes have been develop to meet the purpose. Bombesin (BBN) is an amphibian homolog of mammalian gastrin-releasing peptide (GRP). BBN(7-14), with the amino acid sequence of Gln-Trp-Ala-Val-Gly-His-Leu-Met-NH2, has been extensively used for the development of molecular probes for the imaging of gastrin-releasing peptide receptor (GRPR), after being labeled with various radionuclides. Multiple preclinical studies have demonstrated receptor-specific accumulation of the tracers in GRPR positive tumors. For interests in clinical translation of 68Ga-NOTA-Aca-BBN(7-14), an open-label dynamic whole-body PET/ CT study was designed to investigate the safety and diagnostic performance of 68Ga-NOTA-Aca-BBN(7-14) in patients with glioma.

Official Title
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Safety and Diagnostic Performance of 68Gallium-labeled NOTA-Aca-BBN(7-14) PET/CT in Patients With Primary Gliomas

Conditions
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Glioma

Intervention / Treatment
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* Drug: 68Ga-NOTA-Aca-BBN
* Device: PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be able to provide a written informed consent Clinically based and magnetic resonance imaging (MRI)-based suspected newly diagnosed primary glioma. The tumor will be surgically removed and histological diagnosis will be available. Exclusion Criteria: Females planning to bear a child recently or with childbearing potential； Known severe allergy or hypersensitivity to IV radiographic contrast； Inability to lie still for the entire imaging time because of cough, pain, etc. Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc. Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-NOTA-Aca-BBN(7-14) PET/CT<br>The patients were injected with 111-148 MBq of 68Ga-NOTA-Aca-BBN(7-14) in one dose intravenously and underwent PET/CT scan 30 min later. | Drug: 68Ga-NOTA-Aca-BBN<br>* 68Ga-NOTA-Aca-BBN(7-14) were injected into the patients before the PET/CT scans<br>* Other names: 68Ga-NOTA-Aca-BBN(7-14);Device: PET/CT<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standardized uptake value of 68Ga-NOTA-Aca-BBN(7-14) in primary glioma | The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in primary glioma will be measured. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events collection | Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed. | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bombesin, gastrin-releasing peptide receptor, 68Gallium labeling, PET/CT