68Ga-citrate PET/MR Imaging for Glioma

Study Overview
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Brief Summary
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This is a prospective, single center, open-label study in adult patients with presumed World Health Organization (WHO) grade 3 or 4 glioma who will be undergoing surgical resection as standard of care. In some cases, patients will have had biopsy. Study participants will undergo 68Ga-citrate Positron Emission Tomography / magnetic resonance (PET/MR) prior to surgery.

Official Title
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68Ga-citrate PET/MR Imaging for the Evaluation of Glioma in Adults

Conditions
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Glioma

Intervention / Treatment
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* Drug: 68Ga-citrate PET/MR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: World Health Organization (WHO) grade 3 or 4 glioma planning to undergo surgery Age >= 18 yrs. Karnofsky performance status of >= 60 Ability to understand a written informed consent document, and the willingness to sign it. Cohort A: - Positive for Phosphatase and Tensin Homolog (PTEN) deletion, confirmed by immunohistochemistry of tissue biopsy Cohort B: - Negative for PTEN deletion, confirmed by immunohistochemistry of tissue biopsy Exclusion Criteria: Contraindications to Positron Emission Tomography (PET) imaging (e.g. pregnant or breast-feeding woman) Contraindications to magnetic resonance (MR) imaging (e.g. pacemakers, metallic implants, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Positive for PTEN deletion<br>Confirmed by immunohistochemistry of tissue biopsy | Drug: 68Ga-citrate PET/MR<br>* Study participants will undergo the 68Ga-citrate PET/MR imaging after all screening and baseline assessments have been completed. Patient shall begin imaging between 120 and 360 minutes after the injection of the radiopharmaceutical. Coverage for the scan will extend from the patient's vertex to the neck. The entire imaging study will take roughly 90 minutes.<br>|
| Negative for PTEN deletion<br>Confirmed by immunohistochemistry of tissue biopsy | Drug: 68Ga-citrate PET/MR<br>* Study participants will undergo the 68Ga-citrate PET/MR imaging after all screening and baseline assessments have been completed. Patient shall begin imaging between 120 and 360 minutes after the injection of the radiopharmaceutical. Coverage for the scan will extend from the patient's vertex to the neck. The entire imaging study will take roughly 90 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum standardized uptake value (SUVmax) | The location and extent of 68Ga-citrate uptake will be compared to both same day magnetic resonance imaging (MRI) and subsequent pathology. SUVmax will be the outcome of interest and summarized with descriptive measures. SUVmax will be compared via a two-sided two-sample equal-variance t-test between those patients positive for PTEN deletion and those negative for PTEN deletion. | 1 day |