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

Glioma Clinical Trial

Official title:

Using Advanced MR Imaging to Determine High Risk Areas in Patients With Malignant Gliomas and to Design Potential Radiation Plans: A Pilot Study, and to Examine Metabolite Changes in Gliomas and Other Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00870129
• Other study ID #: 09-009
• Status: Recruiting
• Phase: N/A
• Start date: March 2009
• Est. completion date: September 2024

Study information

• Verified date: December 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Robert Young, MD
• Phone: 212-639-8196
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Brain Cancer
• Brain Neoplasms
• Glioma

Intervention

Procedure:
• MRI and advanced MRI sequences
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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	feasibility of 2HG spectroscopy		2 years

External Links

•   Memorial Sloan Kettering Cancer Center