High Resolution Magnetic Resonance Imaging in Patients with Brain Tumors

Study ID
STU 062010-160

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

Contact
Sarah McNeil
214-648-5573
sarah.mcneil@utsouthwestern.edu

Principal Investigator
Elizabeth Maher

Summary

The study is designed to directly compare the MR images of a brain tumor obtained on the 3T and then 7T MRi in approximately 250 patients followed serially with MR imaging to evaluate for tumor progression. We will consent 250 patients to allow for screen failures and early withdrawals and expect enrollment to be completed in 2 years. once enrolled, subjects will be followed for approximately 5 years or until disease progression or withdrawal of consent.

Patients with primary or metastatic brain tumors will be eligible for this imaging study. eligible study patients will be screened, recruited, and enrolled at uT Southwestern Medical Center in the Harold C. Simmons Comprehensive Cancer Center, university Hospital x Zale Lipshy and university Hospital x St. Paul as well as at Parkland Health and Hospital System. Patients will be scheduled for routine brain MR imaging at the Rogers MRi Center at uT Southwestern as per standard procedures in the neuro-oncology program. at the baseline visit a 3T research MRi scan, as well as a 7T MRi scan, each with 1H-MRS will be obtained. after every 2nd routine follow up clinical MR scan, a 3T research scan will be booked with adequate time to obtain diffusion tensor imaging (DTi) and 1H-MRS (with total scan time up to a maximum of 60 minutes). The time interval between scans is determined by tumor histology and will follow standard clinical procedures. an office visit in the neuro-oncology clinic will follow the clinical brain MRi for review and discussion with the patient by the treating neuro-oncologist or neurosurgeon. at the visit, an interval history will be obtained, medications and adverse events will be reviewed and a neurological examination will be performed. a 7T MRi will be scheduled after every 2nd routine follow up clinical MRi and 3T research scan. This will permit direct comparison of the findings at 3T. 1H-MRS will be performed with each 7T MRi using newly developed sequences to detect intermediary metabolites. if the patient develops clinical symptoms consistent with tumor progression prior to regularly scheduled clinical MRi, he/she will have a clinical MRi for diagnostic purposes and then will undergo imaging on the 3T and 7T MR research scanners. There will be no restrictions on the number of 7T MRis an individual patient can have and patients will be followed as long as they remain willing to participate or until they are unable to participate because of physical limitations due to neurological progression.

each MRi scan and MR spectroscopy result will be reported according to standard image evaluation for the 3T MRi and direct comparison of the abnormal regions reported on the 7T. For example, the extent of abnormality seen with T1-weighted images described above, will be measured in mm for each scan in three dimensions. any additional abnormalities identified at 7T that are not seen at 3T will be reported separately. For each scan, the prior MRi at the same magnet strength will serve as a comparison scan. ongoing review of the data will enable sequence modification to be instituted as necessary without compromising the comparisons between 3T and 7T or the comparison of one time point to another with a patient series.

Participant Eligibility


* Male or female, any age

* Patient must meet at least one of the four following criteria regarding brain tumor diagnosis:
o Histological diagnosis of a brain tumor
o Histological diagnosis of systemic cancer and brain MR imaging suggestive of metastatic disease to the brain
o Pre-operative brain MR imaging suggestive of a brain tumor
o Radiographic diagnosis of brain tumor in an inoperable location (e.g., brainstem)

* Patient able and willing to provide informed consent

* Karnofsky Performance status > 70%

* Life expectancy greater than 3 months

* Negative serum or urine pregnancy test or child bearing potential terminated by surgery, radiation, menopause or current use of two approved methods of birth control

* Patients who are excluded from 7T MR imaging because of titanium implants that are not yet established to be safe at 7T remain eligible for the imaging at 3T
* Spanish speaking participants will be enrolled for this study
* Patients who are 17 years of age or younger will not be allowed to participate in 7T imaging.
*Lactating women will be eligible for participation.
*Subjects with measurable tumor metabolites by imaging will have the opportunity to participate in the blood metabolite measurement sub-study.