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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01263821
Other study ID # 09-0069
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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