18F FDOPA PET/CT or PET/MRI in Measuring Tumors in Patients With Newly Diagnosed or Recurrent Gliomas

Adult Glioblastoma Clinical Trial

Official title:

18F FDOPA PET/CT or PET/MRI in Patients With Gliomas

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02175745
• Other study ID #: BRN0024
• Secondary ID: NCI-2014-01289BR
• Status: Terminated
• Phase: N/A
• First received: June 24, 2014
• Last updated: June 22, 2016
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: June 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This clinical trial compares fluorine F 18 fluorodopa (18F FDOPA) positron emission tomography (PET) with standard magnetic resonance imaging (MRI) in measuring tumors in patients with glioma that is newly diagnosed or recurrent (has returned). 18F FDOPA is a radioactive drug that binds to tumor cells and is captured in images by PET. Computed tomography (CT) and MRI are used with PET to describe information regarding the function, location, and size of the tumor. PET/CT or PET/MRI may be more accurate than standard MRI in helping doctors find and measure brain tumors.

Description:

PRIMARY OBJECTIVES:

I. To evaluate 18F-FDOPA PET obtained from PET/CT or PET/MRI imaging in patients with newly diagnosed or recurrent gliomas.

OUTLINE:

Patients receive 18F FDOPA intravenously (IV) and then undergo PET/CT or PET/MRI 10-30 minutes later.

After completion of study, patients are followed up at 24 hours and at 1 week.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Provides written informed consent

• Suspected new diagnosis or suspected recurrence of glioma

• Able to remain still for duration of each imaging procedure (about 20 minutes)

Exclusion Criteria:

• Unable to provide informed consent

• Inability to lie still for the entire imaging time

• Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)

• Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adult Anaplastic Ependymoma
• Adult Anaplastic Oligodendroglioma
• Adult Brain Stem Glioma
• Adult Diffuse Astrocytoma
• Adult Giant Cell Glioblastoma
• Adult Glioblastoma
• Adult Gliosarcoma
• Adult Mixed Glioma
• Adult Oligodendroglioma
• Adult Pilocytic Astrocytoma
• Adult Pineal Gland Astrocytoma
• Adult Subependymal Giant Cell Astrocytoma
• Astrocytoma
• Childhood High-grade Cerebellar Astrocytoma
• Childhood High-grade Cerebral Astrocytoma
• Childhood Low-grade Cerebellar Astrocytoma
• Childhood Low-grade Cerebral Astrocytoma
• Ependymoma
• Glioblastoma
• Glioma
• Gliosarcoma
• Neoplasms, Neuroepithelial
• Oligodendroglioma
• Optic Nerve Glioma
• Recurrent Adult Brain Tumor
• Recurrent Childhood Anaplastic Astrocytoma
• Recurrent Childhood Anaplastic Oligoastrocytoma
• Recurrent Childhood Anaplastic Oligodendroglioma
• Recurrent Childhood Brain Stem Glioma
• Recurrent Childhood Cerebellar Astrocytoma
• Recurrent Childhood Cerebral Astrocytoma
• Recurrent Childhood Diffuse Astrocytoma
• Recurrent Childhood Fibrillary Astrocytoma
• Recurrent Childhood Gemistocytic Astrocytoma
• Recurrent Childhood Giant Cell Glioblastoma
• Recurrent Childhood Glioblastoma
• Recurrent Childhood Gliomatosis Cerebri
• Recurrent Childhood Gliosarcoma
• Recurrent Childhood Oligoastrocytoma
• Recurrent Childhood Oligodendroglioma
• Recurrent Childhood Pilomyxoid Astrocytoma
• Recurrent Childhood Protoplasmic Astrocytoma
• Recurrent Childhood Subependymal Giant Cell Astrocytoma
• Recurrent Childhood Visual Pathway and Hypothalamic Glioma
• Recurrent Childhood Visual Pathway Glioma
• Untreated Childhood Anaplastic Astrocytoma
• Untreated Childhood Anaplastic Oligoastrocytoma
• Untreated Childhood Anaplastic Oligodendroglioma
• Untreated Childhood Brain Stem Glioma
• Untreated Childhood Cerebellar Astrocytoma
• Untreated Childhood Cerebral Astrocytoma
• Untreated Childhood Diffuse Astrocytoma
• Untreated Childhood Fibrillary Astrocytoma
• Untreated Childhood Gemistocytic Astrocytoma
• Untreated Childhood Giant Cell Glioblastoma
• Untreated Childhood Glioblastoma
• Untreated Childhood Gliomatosis Cerebri
• Untreated Childhood Gliosarcoma
• Untreated Childhood Oligoastrocytoma
• Untreated Childhood Oligodendroglioma
• Untreated Childhood Pilomyxoid Astrocytoma
• Untreated Childhood Protoplasmic Astrocytoma
• Untreated Childhood Subependymal Giant Cell Astrocytoma
• Untreated Childhood Visual Pathway and Hypothalamic Glioma
• Untreated Childhood Visual Pathway Glioma

Intervention

Drug:
• fluorine F 18 fluorodopa
Given IV

Procedure:
• positron emission tomography
Undergo 18F FDOPA PET/CT or PET/MRI
• computed tomography
Undergo 18F FDOPA PET/CT or PET/MRI
• magnetic resonance imaging
Undergo 18F FDOPA PET/CT or PET/MRI

Locations

Country	Name	City	State
United States	Stanford University Hospitals and Clinics	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Erik Mittra	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of suspicious lesions identified by 18F FDOPA PET	The percentage of 18F FDOPA PET positive lesions minus the percentage of conventional imaging positive lesions will be estimated. The significance of the increment will be evaluated by the McNemar test. If the number of lesions per patient allows, nonlinear mixed effects models will be used to evaluate the potential effect of clustering within patient.	Up to 30 minutes post-injection (at time of scan)	No
Primary	Percent agreement of 18F FDOPA PET with pathology	For the subset of lesions where pathology is available (mainly biopsied lesions), the accuracy of 18F FDOPA PET as percent agreement with pathology will be calculated. If the number of biopsy positive lesions is at least 10, an estimate of sensitivity will be calculate; if the number of biopsy negative lesions is at least 10 an estimate of specificity will be calculated.	Up to 30 minutes post-injection (at time of scan)	No