Magnetic Resonance (MR) Imaging to Determine High Risk Areas in Patients With Malignant Gliomas and to Design Potential Radiation Plans and to Examine Metabolite Changes in Gliomas and Other Solid Tumors

NCT00870129 | Recruiting

• 1 other identifier: 09-009
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

The researchers think that the use of advanced MR imaging may help people with this disease, because it may better predict areas within a malignant glioma (brain tumor) that are at a high risk of recurring. WeThe reserchers are doing this study to see whether this advanced imaging is a safe treatment that causes few or mild side effects in people with brain tumors.

Conditions

Brain Cancer; Glioma

Keywords

brain tumor; radiation; MRI; 09-009

Outcome Measures

Primary Outcomes (1)

• To assess the utility of baseline advanced MRI & changes between baseline & follow up advanced MRI in predicting high risk areas that are likely to develop progressive glioma despite chemoradiotherapy.

  1 -7 weeks before radiation treatment, about two months after treatment, and about every two months thereafter for the duration of the study.

Secondary Outcomes (2)

• To compare radiation therapy simulations in patients with gliomas using conventional and baseline advanced MRI data.

  prior to and 1 months±3 weeks after radiation therapy.

• feasibility of 2HG spectroscopy

  2 years

Study Arms (1)

MRI

EXPERIMENTAL

The advanced MRI studies will be obtained at the time of the routinely scheduled preoperative planning MRI and/or the routinely scheduled pre-RT planning MRI at approximately 3±2 weeks after surgery. The routine sequences obtained for the planning MRI are standard of care. The advanced MRI sequences may or may not be additional as some have already been adopted into the standard of care imaging at MSKCC.

Procedure: MRI and advanced MRI sequences

Interventions

MRI and advanced MRI sequences PROCEDURE

This is a nonrandomized study in which each patient will receive the standard clinical care (in the form of surgery, radiation therapy and/or chemotherapy), as per the treating physician. Surgical resection will be performed at the discretion of the treating Neurooncologist and/or Neurooncology Tumor Board. Advanced brain MRIs with the 2 (or, in some cases, 3) special sequences will be obtained at the time of the clinically scheduled contrast MRIs, which are usually obtained immediately prior to and 1 months±3 weeks after radiation therapy if the patient requires radiation therapy for his/her tumor. The advanced brain MRI may also be obtained before surgery for suspected or confirmed gliomas, as per the standard of care, in some patients who may or may not require radiation therapy.

MRI

Eligibility Criteria

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

You may qualify if:

• Suspected or Histopathologically proven diagnosis of high grade or low glioma or tumor is suspected to harbor an isocitrate dehydrogenase (IDH) mutation
• May undergo radiation therapy
• Patient and/or guardian is able to provide written informed consent prior to study registration
• Age ≥ 18 years old

You may not qualify if:

• Extreme claustrophobia that precludes MRI scan
• Known allergic reaction to Gd-DTPA
• Any contraindication to gadolinium intravenous contrast as per standard Department of Radiology contrast guidelines
• Any absolute contraindication to MRI (e.g., pacemaker, aneurysm clip, tissue expander).
• Pregnant or nursing female
• Unable to cooperate for MRI and/or radiation therapy planning

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Brain Neoplasms; Glioma

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Robert Young, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Young, MD

CONTACT

212-639-8196

Sunitha Thakur, PhD

CONTACT

646-608-8262

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: March 26, 2009
• First Posted: March 27, 2009
• Study Start: March 1, 2009
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 10, 2025

Record last verified: 2025-10

Locations

US (1)