18F-DOPA-PET in Planning Surgery in Patients With Gliomas

Malignant Glioma Clinical Trial

Official title:

Evaluating the Impact of 18F-DOPA-PET on Neurosurgical Planning for Gliomas

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02020720
• Other study ID #: MC1373
• Secondary ID: NCI-2013-02373MC
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: January 22, 2014
• Est. completion date: December 15, 2024

Study information

• Verified date: June 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: December 15, 2024
• Est. primary completion date: October 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Glioma
• Malignant Glioma
• Recurrent Brain Neoplasm

Intervention

Procedure:
• Biopsy
Undergo image-guided biopsy
• Computed Tomography
Undergo 18F-DOPA-PET/CT
• Diffusion Weighted Imaging
Undergo DTI

Drug:
• Fluorine F 18 Fluorodopa
Undergo 18F-DOPA-PET/CT

Other:
• Laboratory Biomarker Analysis
Correlative studies

Procedure:
• Perfusion Magnetic Resonance Imaging
Undergo pMRI
• Positron Emission Tomography
Undergo 18F-DOPA-PET/CT
• Therapeutic Conventional Surgery
Undergo stereotactic craniotomy

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Accurate identification of the highest grade/highest density disease	Paired t-test statistical analysis will be used to evaluate differences in volumes identified using biopsy-validated thresholds as highly aggressive disease comparing 18F-DOPA uptake and relative cerebral blood volume from pMRI.	Up to 5 years
Other	Accurate identification of tumor extent	Paired t-test statistical analysis will be used to evaluate differences in volumes identified using biopsy-validated thresholds as disease extent comparing 18F-DOPA PET and diffusion maps from DTI.	Up to 5 years
Other	Role of metabolic imaging in neurosurgical resection planning	Paired t-test analysis will be performed to determine the level of statistical significance between conventional MRI only and PET + MRI volumes.	Up to 5 years
Primary	Ratios of maximum tumor standardized uptake value (SUVmax) normalized to mean SUV (SUVmean) of T/N	To determine the optimal PET threshold for distinguishing HGG from LGG brain tissue, receiver operating characteristic (ROC) analysis and the Youden's index (sum of the sensitivity and specificity - 1) will be used. The Youden's index will be calculated for each possible T/N threshold. The final ROC area under the curve (AUC) value and confidence intervals will be estimated using ROC analysis methods for clustered continuous data as described by Obychowski.	Up to 5 years
Secondary	Differences in volumes generated from biopsy-validated thresholds evaluated by 18F-DOPA-PET, pMRI, and DTI	Paired t-test statistical analysis will be performed to determine if any differences exist and the level of statistical significance between volumes.	Up to 5 years
Secondary	Histologic grade of the specimen defined as HGG, LGG, or non-malignant brain tissue	The relationship between these T/N values, MRI contrast enhancement values, and the histologic grade of the specimen (HGG, LGG, or non-malignant brain tissue) will be determined using multivariate linear regression. These models will also include as appropriate the specimen cellularity and necrosis values.	Up to 5 years
Secondary	MRI contrast enhancement values	The relationship between these T/N values, MRI contrast enhancement values, and the histologic grade of the specimen (HGG, LGG, or non-malignant brain tissue) will be determined using multivariate linear regression. These models will also include as appropriate the specimen cellularity and necrosis values.	Up to 5 years
Secondary	Progression free survival		The time from study entry to progression, assessed up to 5 years
Secondary	Proportion of patients whose maximum 18F-DOPA uptake samples are in agreement with the final diagnostic grade	Associated confidence intervals will be estimated based on dividing the number of patients whose samples agree by the total number of patients.	Up to 5 years