Image Guided Therapy in the Treatment of Gliomas

Glioma Clinical Trial

Official title:

Image Guided Adaptive Multi-modality Therapy in the Treatment of Gliomas

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01263821
• Other study ID #: 09-0069
• Status: Terminated
• Phase: N/A
• First received: December 16, 2010
• Last updated: August 3, 2017
• Start date: August 2009
• Est. completion date: April 2014

Study information

• Verified date: August 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

PRIMARY OBJECTIVES:

I. To correlate the imaging findings with pathological grade following surgery in patients with newly diagnosed intra-cranial gliomas.

SECONDARY OBJECTIVES:

I. To determine the feasibility of defining the optimal target volume for radiation therapy using MR spectroscopy, diffusion, perfusion and functional imaging. II. To monitor therapeutic responses following treatment using MR spectroscopy, diffusion imaging and perfusion study.

III. To monitor changes in neurocognitive functioning following image guided therapy.

OUTLINE: 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. After completion of study treatment, patients are followed up every 3 months for the first year then every 6 months for another year.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Glioma

Intervention

Procedure:
• Diffusion-weighted magnetic resonance imaging
Undergo diffusion-weighted MRI
• Perfusion-weighted magnetic resonance imaging
Undergo perfusion-weighted magnetic resonance imaging
• Functional magnetic resonance imaging
Undergo functional MRI
• Magnetic resonance spectroscopic imaging
Undergo MR spectroscopic imaging
• Therapeutic conventional surgery
Undergo maximal surgical resection
• Quality-of-life assessment
Ancillary studies
• Radiation therapy treatment planning/simulation
Undergo IMRT planning
• Intensity-modulated radiation therapy
Undergo intensity-modulated radiation therapy

Other:
• Questionnaire administration
Ancillary studies

Locations

Country	Name	City	State
United States	NYU Cancer Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Clinical efficacy of this biological image-guided treatment in gliomas		Twice a year, after enrollment of first 25 patients, and at study completion