Clinical trial NCT02020720: 18F-DOPA-PET in Planning Surgery in Patients With Gliomas
Official title: Evaluating the Impact of 18F-DOPA-PET on Neurosurgical Planning for Gliomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Malignant Glioma
Recurrent Brain Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-12-25
Enrollment: 72
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This pilot clinical trial studies fluorine F 18 fluorodopa (18F-DOPA)-positron emission tomography (PET) in planning surgery in patients with gliomas. New imaging procedures, such as 18F-DOPA-PET scan, may help find gliomas and may help in planning surgery.

Detailed description: PRIMARY OBJECTIVES:

I. Accurately define a standardized 18F-DOPA PET tumor/normal tissue (T/N) threshold to delineate high grade gliomas (HGG) from low grade gliomas (LGG).

SECONDARY OBJECTIVES:

I. Determine correlation between 18F-DOPA PET activity, magnetic resonance imaging (MRI) contrast enhancement and high- or low-grade glioma biopsies.

II. Compare grade from maximum 18F-DOPA uptake samples for all resection patients against the final diagnostic grade, based on the highest grade component from all stereotactic and non-stereotactic samples acquired for open resection patients.

III. Compare volume differences between 18F-DOPA PET activity, MRI contrast enhancement, perfusion MRI (pMRI), and diffusion tensor imaging (DTI) for neurosurgical planning.

IV. Assess the time to progression for patients receiving resections and biopsies only.

TERTIARY OBJECTIVES:

I. Compare histopathology correlations with 18F-DOPA PET against correlations with perfusion MR imaging for accurate identification of the highest grade/highest density disease.

II. Compare histopathology correlations with 18F-DOPA PET against correlations with diffusion tensor imaging information for accurate identification of tumor extent.

III. Compare neurosurgical resection extent volume delineation with and without 18F-FDOPA-PET metabolic imaging information to determine role of metabolic imaging in neurosurgical resection planning.

OUTLINE:

Within 1 week of biopsy or resection, patients undergo 18F-DOPA PET/computed tomography (CT) scan and pMRI and DTI at baseline. Patients then undergo stereotactic craniotomy or image-guided biopsy.

After completion of study treatment, patients are followed up yearly for 5 years.

Eligibility criteria: Inclusion Criteria:

* MRI findings compatible with newly diagnosed or recurrent high- or low-grade malignant glioma
* Planned craniotomy and resection or biopsy
* Willing to sign release of information for any radiation and/or follow-up records
* Provide informed written consent if \>= 18 years; if \< 18 years, provide informed written assent and parent or legal guardian provide informed written consent
* Ability to provide tissue for mandatory correlative research component

Exclusion Criteria:

* Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure)
* Unable to undergo an 18F-DOPA PET scan (e.g. Parkinson's disease, taking anti-dopaminergic, or dopamine agonist medication or less than 6 half-lives from discontinuance of dopamine agonists; NOTE: other potentially interfering drugs: amoxapine, amphetamine, benztropine, buproprion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, paroxetine, citalopram, and sertraline; if a patient is on any of these drugs, list which ones on the on-study form
* Any of the following:

  * Pregnant women
  * Nursing women
  * Men or women of childbearing potential who are unwilling to employ adequate contraception

Primary outcomes:
measure: Ratios of maximum tumor standardized uptake value (SUVmax) normalized to mean SUV (SUVmean) of T/N
timeFrame: Up to 1 year
Secondary outcomes:
measure: Differences in volumes generated from biopsy-validated thresholds evaluated by 18F-DOPA-PET, pMRI, and DTI
timeFrame: Up to 5 years
measure: Histologic grade of the specimen defined as HGG, LGG, or non-malignant brain tissue
timeFrame: Up to 5 years
measure: MRI contrast enhancement values
timeFrame: Up to 5 years
measure: Progression free survival
timeFrame: The time from study entry to progression, assessed up to 5 years
measure: Proportion of patients whose maximum 18F-DOPA uptake samples are in agreement with the final diagnostic grade
timeFrame: Up to 5 years
Other outcomes:
measure: Accurate identification of the highest grade/highest density disease
timeFrame: Up to 5 years
measure: Accurate identification of tumor extent
timeFrame: Up to 5 years
measure: Role of metabolic imaging in neurosurgical resection planning
timeFrame: Up to 5 years
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Nadia N. Laack, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic in Rochester
name: Debra H. Brinkmann, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: