Pilot Study Using Amide Proton Transfer Magnetic Resonance Imaging Distinguishing Glioma

Stopped early · Not applicable

Conditions studied: Gliosarcoma, Glioma

In brief

This research is being done to study the pattern of changes in various parts of the magnetic resonance imaging (MRI) studies that patients have done to help plan their radiation therapy and to evaluate the effects of therapy. The MRI of the brain is one of the major ways a participant's doctors determine how to treat a participant's tumor and if the participant's tumor is growing or not. In this study the investigators want to learn if new sequences added to the MRI that the investigators are already getting to guide partipants' radiation treatment can be analyzed to help make better treatment decisions. MRI sequences that examine the composition and structure of the tissues in the brain in a different way will be obtained. These are called called Amide Proton Transfer (APT) and Diffusion Weighted MRI. These scans will first be performed at the time of participants' radiation plannings scan done before treatment and near the end of the course of radiation treatments. This will allow the study team to investigate if there are changes in these sequences before radiation treatment and to see if using these MRI studies will allow us to better plan radiation treatments for patients in the future. This pre-treatment scan will be done at the same time as participants' standard radiation planning MRI, but will cause the scan to take longer. Participants will also have an extra MRI during one of the last 5 days of the planned 28-33 radiation treatments that are standardly used. This additional scan will not include administration of injected contrast agents, and would occur on a day when participants are also coming in for radiation. This scan will be compared with the first scan. The investigators will determine whether these changes may predict later long term outcome of treatment for patients. Patients who enroll in this study will get all of the standard therapy they would get for their tumor whether or not they participate in this study. There is no extra or different therapy given. The investigators anticipate that the radiation treatment volumes created using APT will largely overlap with the conventional plan but will be distinct at the margins. Disease failure is more likely to occur in areas with APT abnormalities suggestive of active tumor. In patients that have failure outside the contrast enhancing area, the region of failure will be predicted by regions of increased APT activity. Current MRI sequences do not allow for prediction of regions of recurrence or progression, or distinguish between tumor, pressure, or surgical injury as the cause of FLAIR/T2 abnormalities. Disease failure is more likely to occur in areas with APT abnormalities suggestive of active tumor. In patients that have failure outside the contrast enhancing area, the region of failure will be predicted by regions of increased APT activity. Current MRI sequences do not allow for prediction of regions of recurrence or progression, or distinguish between tumor, pressure, or surgical injury as the cause of FLAIR/T2 abnormalities. Volume containing elevated APT signal may be associated with outcome (survival). In an exploratory analysis, the investigators will evaluate whether there are characteristic patterns that should be prospectively studied in a larger trial.

Key facts

Study ID

NCT03843814

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

13

Starts

2014-08-01

Expected to finish

2017-12-13

Last updated by the study team

2019-11-26

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pathologically Confirmed Glioma after completion of planned biopsy or resection.
• High grade glioma histologies:
• Glioblastoma
• High Grade or Malignant Glioma
• Anaplastic Astrocytoma
• Anaplastic Oligodendroglioma
• Gliosarcoma
• Mixture of any of the above histologies Low Grade Histologies
• Astrocytoma
• Grade II or low grade glioma
• Oligodendroglioma
• Mixtures of the above histologies
• Plan to undergo external radiation treatment as part of therapy
• No prior therapeutic cranial radiotherapy
• Can safely perform clinically indicated MRI (no contraindications to MRI with Gadolinium) as determined by the standard Johns Hopkins Radiation Oncology screening procedures,

You may not qualify if…

• Patients who cannot undergo MRIs.
• Patients who are allergic to gadolinium based contrast agent
• Patients who have cardiac pacemaker or other electronic or metal implant
• Patients who have chronic kidney disease judged sufficient to exclude them from the clinically indicated contrast enhanced MRI.
• Female patients who is pregnant

Where it is running

• The SKCCC at Johns Hopkins — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.