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| ID | Type | Description | Link |
|---|---|---|---|
| 24-000426 | Other Identifier | Mayo Clinic Institutional Review Board | |
| R01FD007842 | U.S. FDA Grant/Contract | View source |
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| Name | Class |
|---|---|
| Food and Drug Administration (FDA) | FED |
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This phase II trial studies how well the addition of 18F-DOPA (amino acid) positron emission tomography (PET)/computed tomography (CT) to standard of care (SOC) imaging can improve the clinical management of patients with brain tumors in over 50% of cases. PET is an imaging test that helps to measure the information about functions of tissues and organs within the body. A PET scan uses a radioactive drug (radiotracer) to show this activity. CT scan uses X-rays to create images of the bones and internal organs within the body. Combining a PET scan with a CT scan can help make the images easier to interpret. PET/CT scans are hybrid scanners that combine both of the two modalities into a single scan. This allows images of both anatomy (CT) and function (PET) to be taken during the same scan. The 18F-DOPA PET/CT scan is done with a very small amount of a radioactive tracer called FDOPA. The PET/CT scan is then used to detect the location of tumors. Using the 18FDOPA-PET/CT scan in addition to the SOC scan may improve the clinical management of patients with brain tumors.
PRIMARY OBJECTIVE:
I. To determine whether the addition of amino acid PET to standard of care imaging impacts clinical management of brain tumor patients in over 50% of cases.
SECONDARY OBJECTIVES:
I. To assess the safety and tolerability of amino acid PET for brain tumor patients in response to Food and Drug Administration (FDA) guidance that such data is needed to support a potential New Drug Application (NDA) for fluorodopa F 18 (18F-DOPA).
II. To assess the rate of identification of tumor outside of standard magnetic resonance imaging (MRI) imaging.
OUTLINE:
Patients receive 18F-DOPA intravenously (IV) and undergo PET/CT over 30 minutes on day 1.
After completion of study intervention, patients are followed for 3 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (18F-DOPA) | Experimental | Patients receive 18F-DOPA IV and undergo PET/CT over 30 minutes on day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Undergo PET/CT |
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| Measure | Description | Time Frame |
|---|---|---|
| Impact of 18F-DOPA PET/CT on clinical management | Will be measured using the Amino Acid PET Imaging Survey, to be completed by the provider after participant has received fluorodopa F 18 (18F-DOPA) positron emission tomography (PET)/computed tomography (CT). The survey consists of 4 questions, 1 multiple choice (what will PET scan be used for); 2 yes/no and one open-ended question related with how PET scan did or did not make a clinically meaningful impact in the management of patient care. | 3 days post-PET scan, up to 64 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | 3 days post-PET scan, up to 64 days |
| Rate of identification of tumor outside of standard magnetic resonance imaging (MRI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Derek R. Johnson, MD | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
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| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C043437 | fluorodopa F 18 |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Fluorodopa F 18 | Drug | Given IV |
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| Positron Emission Tomography | Procedure | Undergo PET/CT |
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Will be measured using the Amino Acid PET Imaging Survey, to be completed by the provider after participant has received fluorodopa F 18 (18F-DOPA) positron emission tomography (PET)/computed tomography (CT). The survey consists of 4 questions, 1 multiple choice (what will PET scan be used for); 2 yes/no (including whether a tumor outside of MRI contrast enhancement was identified); and one open-ended question related with how PET scan did or did not make a clinically meaningful impact in the management of patient care.
| 3 days post-PET scan, up to 64 days |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |