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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

Primary Purpose

Brain Cancer, Glioma

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

MRI and advanced MRI sequences

About this trial

This is an interventional diagnostic trial for Brain Cancer focused on measuring brain tumor, radiation, MRI, 09-009

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Memorial Sloan Kettering Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRI

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

feasibility of 2HG spectroscopy

Full Information

NCT ID

NCT00870129

First Posted

March 26, 2009

Last Updated

January 27, 2023

Sponsor

Memorial Sloan Kettering Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT00870129

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 2009 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Cancer, Glioma

Keywords

brain tumor, radiation, MRI, 09-009

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MRI

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

MRI and advanced MRI sequences

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Time Frame

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

Title

feasibility of 2HG spectroscopy

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Robert Young, MD

Phone

212-639-8196

First Name & Middle Initial & Last Name or Official Title & Degree

Sunitha Thakur, PhD

Phone

646-608-8262

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Young, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert Young, MD

Phone

212-639-8196

First Name & Middle Initial & Last Name & Degree

Sunitha Thakur, PhD

First Name & Middle Initial & Last Name & Degree

Robert Young, MD

12. IPD Sharing Statement

Links:

URL

http://www.mskcc.org

Description

Memorial Sloan Kettering Cancer Center

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