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

NCT02020720 | Completed Early Phase 1

• 5 other identifiers: MC1373P50CA108961R01CA178200NCI-2013-0237313-005102
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Glioma; Recurrent Brain Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 1 year

Secondary Outcomes (5)

• Differences in volumes generated from biopsy-validated thresholds evaluated by 18F-DOPA-PET, pMRI, and DTI

  Up to 5 years

• Histologic grade of the specimen defined as HGG, LGG, or non-malignant brain tissue

  Up to 5 years

• MRI contrast enhancement values

  Up to 5 years

• Progression free survival

  The time from study entry to progression, assessed up to 5 years

• Proportion of patients whose maximum 18F-DOPA uptake samples are in agreement with the final diagnostic grade

  Up to 5 years

Other Outcomes (3)

• Accurate identification of the highest grade/highest density disease

  Up to 5 years

• Accurate identification of tumor extent

  Up to 5 years

• Role of metabolic imaging in neurosurgical resection planning

  Up to 5 years

Study Arms (1)

Diagnostic (18F-DOPA-PET)

EXPERIMENTAL

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

Procedure: Biopsy; Procedure: Computed Tomography; Procedure: Diffusion Weighted Imaging; Drug: Fluorine F 18 Fluorodopa; Other: Laboratory Biomarker Analysis; Procedure: Perfusion Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Procedure: Therapeutic Conventional Surgery

Interventions

Biopsy PROCEDURE

Undergo image-guided biopsy

Also known as: Bx

Diagnostic (18F-DOPA-PET)

Computed Tomography PROCEDURE

Undergo 18F-DOPA-PET/CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography

Diagnostic (18F-DOPA-PET)

Diffusion Weighted Imaging PROCEDURE

Undergo DTI

Also known as: Diffusion Weighted MRI, Diffusion-Weighted Magnetic Resonance Imaging, Diffusion-Weighted MR Imaging, Diffusion-Weighted MRI, DWI, DWI MRI, DWI-MRI, MR Diffusion-Weighted Imaging

Diagnostic (18F-DOPA-PET)

Fluorine F 18 Fluorodopa DRUG

Undergo 18F-DOPA-PET/CT

Also known as: 18F-FDOPA

Diagnostic (18F-DOPA-PET)

Laboratory Biomarker Analysis OTHER

Correlative studies

Diagnostic (18F-DOPA-PET)

Perfusion Magnetic Resonance Imaging PROCEDURE

Undergo pMRI

Also known as: magnetic resonance perfusion imaging

Diagnostic (18F-DOPA-PET)

Positron Emission Tomography PROCEDURE

Undergo 18F-DOPA-PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Diagnostic (18F-DOPA-PET)

Therapeutic Conventional Surgery PROCEDURE

Undergo stereotactic craniotomy

Diagnostic (18F-DOPA-PET)

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Glioma; Brain Neoplasms

Interventions

Biopsy; fluorodopa F 18; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Nadia N. Laack, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

• Debra H. Brinkmann, Ph.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: December 25, 2013
• Study Start: January 22, 2014
• Primary Completion: October 25, 2019
• Study Completion: January 10, 2024
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

US (1)