Pilot Study Using Amide Proton Transfer Magnetic Resonance Imaging Distinguishing Glioma

NCT03843814 | Terminated DMC

• 2 other identifiers: J1439IRB00032866
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gliosarcoma; Glioma

Keywords

MRI (Magnetic Resonance Imaging) of the brain; Amide Proton Transfer (APT); Diffuse Weighted Imaging (DWI)

Outcome Measures

Primary Outcomes (1)

• Standard planning versus Amide Proton Transfer (APT) imaging planning

  Difference in radiation target volumes between standard MRI and Amide Proton Transfer (APT) imaging.

  day 23-28 post radiation treatment

Secondary Outcomes (4)

• tumor recurrence

  up to 3 years

• Survival

  up to 3 years

• Time to absolute change in voxels of APT and DWI (diffusion weighted imaging) signals from baseline to end of radiation treatment

  Change from Baseline to Days 23-28 post-radiation treatment

• Change in voxels of APT and DWI signals

  up to 3 years or until death, whichever occurs first.

Study Arms (1)

APT MRI

EXPERIMENTAL

Participants will have the standard MRI of the brain that is performed for radiation planning for brain tumors. 1. Addition of the additional MRI sequences to the standard MRI before radiation therapy. This typically adds 10-15 minutes to the length of the scan. 2. An additional MRI scan to be scheduled during one of the final five radiation treatment days that would not otherwise occur. There will be no contrast injection as part of this second scan. This may typically take 40-45 minutes. 3. Collection of information about participants' tumor, including copies of their MRIs and later outcome of treatment.

Procedure: APT MRI

Interventions

APT MRI PROCEDURE

APT MRI

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

The SKCCC at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Gliosarcoma; Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Lawrence Kleinberg, M.D.

  The SKCCC at Johns Hopkins

  PRINCIPAL INVESTIGATOR

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: September 18, 2014
• First Posted: February 18, 2019
• Study Start: August 1, 2014
• Primary Completion: December 13, 2017
• Study Completion: December 13, 2017
• Last Updated: November 26, 2019

Record last verified: 2019-11

Locations

US (1)