Image Guided Therapy in the Treatment of Gliomas

NCT01263821 | Terminated DMC

• 1 other identifier: 09-0069
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: New imaging techniques using magnetic resonance imaging give better tumor definition, thus may lead to better tumor targeting and avoid damaging critical parts of normal brain. PURPOSE: This phase I/II trial is studying how well image-guided therapy works in treating patients with newly diagnosed intracranial glioma.

Conditions

Glioma

Keywords

glioma; biologic imaging; magnetic resonance spectroscopy; magnetic resonance imaging; perfusion imaging; diffusion imaging; functional magnetic resonance imaging; radiation therapy; intensity modulated radiation therapy

Outcome Measures

Primary Outcomes (1)

• Feasibility of identifying low grade and high grade tumor location with imaging techniques that include MRSI,perfusion MRI, and DTI

  Twice a year, after enrollment of first 25 patients, and at study completion

Secondary Outcomes (2)

• Incorporate imaging techniques of MRSI, perfusion MRI and DTI into the radiotherapy treatment planning system for target delineation

  Twice a year, after enrollment of first 25 patients, and at study completion

• Clinical efficacy of this biological image-guided treatment in gliomas

  Twice a year, after enrollment of first 25 patients, and at study completion

Study Arms (1)

Arm I

EXPERIMENTAL

Patients undergo magnetic resonance spectroscopic imaging, functional magnetic resonance imaging (MRI), diffusion-weighted MRI, and perfusion-weighted MRI. Patients then undergo maximum surgical resection followed by intensity-modulated radiation therapy (IMRT) 5 days a week for 6 weeks.

Procedure: Diffusion-weighted magnetic resonance imaging; Procedure: Perfusion-weighted magnetic resonance imaging; Procedure: Functional magnetic resonance imaging; Procedure: Magnetic resonance spectroscopic imaging; Procedure: Therapeutic conventional surgery; Procedure: Quality-of-life assessment; Procedure: Radiation therapy treatment planning/simulation; Procedure: Intensity-modulated radiation therapy; Other: Questionnaire administration

Interventions

Diffusion-weighted magnetic resonance imaging PROCEDURE

Undergo diffusion-weighted MRI

Also known as: Diffusion-weighted MRI

Arm I

Perfusion-weighted magnetic resonance imaging PROCEDURE

Undergo perfusion-weighted magnetic resonance imaging

Also known as: Perfusion-weighted MRI

Arm I

Functional magnetic resonance imaging PROCEDURE

Undergo functional MRI

Also known as: fMRI, functional MRI

Arm I

Magnetic resonance spectroscopic imaging PROCEDURE

Undergo MR spectroscopic imaging

Also known as: 1H-nuclear MRSI, Proton MRSI

Arm I

Therapeutic conventional surgery PROCEDURE

Undergo maximal surgical resection

Arm I

Quality-of-life assessment PROCEDURE

Ancillary studies

Arm I

Radiation therapy treatment planning/simulation PROCEDURE

Undergo IMRT planning

Arm I

Intensity-modulated radiation therapy PROCEDURE

Undergo intensity-modulated radiation therapy

Also known as: IMRT

Arm I

Questionnaire administration OTHER

Ancillary studies

Arm I

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:

• Histologically confirmed, newly diagnosed intracranial glioma
• A diagnostic contrast enhanced CT/MRI demonstrating the lesion prior to registration
• Karnofsky performance status \>= 60
• Ability to undergo MR imaging with the use of Gadolinium dye
• Patient must sign a study specific informed consent form; if the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the patient's legal representative

You may not qualify if:

• Inability to obtain histological proof of glioma
• Allergy to Gadolinium contrast
• Any condition including metallic implants or cardiac pace makers that make the candidate ineligible for MR imaging
• Any medical condition including renal or cardiac insufficiency that make the candidate a high risk for gadolinium contrast administration
• Karnofsky performance status of =\< 50
• Prior history of radiation therapy to the brain
• Pregnancy

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Cancer Institute

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Glioma

Interventions

Magnetic Resonance Spectroscopy; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Joshua Silverman, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2010
• First Posted: December 21, 2010
• Study Start: August 1, 2009
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: August 4, 2017

Record last verified: 2017-08

Locations

US (1)