Clinical Development of MR Spectroscopy and Imaging in Brain Cancers

Study ID
STU 122013-077

Cancer Related
Yes

Healthy Volunteers
Yes

Study Sites

  • UT Southwestern-Other

Contact
Jeannie Baxter
214/645-2726
JEANNIE.BAXTER@UTSouthwestern.edu

Principal Investigator
Changho Choi

Summary

The research task is twofold. First, we aim to transfer our 2HG MRS data acquisition protocol, which was developed in a Philips 3T research scanner at the advanced imaging Research Center (aiRC), into a clinical MR center (Rogers MRi Center) at uTSW which has Philips 1.5T and 3T scanners. Since these systems are the same model (Philips achieva), the MRS protocol of the aiRC research scanner can be directly applied in the clinical scanner. 2HG MRS will also be translated into a Ge 3T scanner at the Meadows imaging Center (Parkland). Since the MRS sequence components are different between MR vendors, the existing MRS sequence in the Ge scanner will require some refining of data acquisition parameters for maximizing the 2HG signal selectivity. This will be done in a similar fashion to the Pi's prior sequence optimization procedure at the aiRC research scanner. at both clinical MR centers, MR techs will be trained for proper positioning of the volume of interest (Voi) and positioning of shimming volumes. MRS data analysis is a critical part for obtaining reliable metabolite estimates. automation of spectral analysis for 2HG estimation will be established in the Pi's lab and progressively transferred to radiologists in clinics over the 3-year project period.

Second, we aim to establish disease specification of 2HG. We will assess 2HG in patients with clinically-proven brain metastasis, multiple sclerosis, epilepsy, stroke, or encephalitis.

after the project is successfully completed, 2HG evaluation can be done in a clinical setting without the need of bringing the patients to a research scanner. We aim to make it possible to incorporate 2HG imaging in a regular clinical follow-up and to have the tumor status associated with 2HG readily available to clinicians. We will consider the study completed when the 2HG estimation solely by clinical radiology MR technologists is equivalent to those by the research personnel at aiRC. Statistically meaningful comparison between clinical and research scanners will require 2HG measurements over the entire project period.

We aim to have 2HG MRS scans in 175 subjects for aims 1 and 2, which include 120 with gliomas (scans at Rogers and aiRC), 50 with non-glioma brain diseases (scans at Rogers or Meadows), and 5 healthy volunteers (scans at Meadows). assuming screen failures and/or withdrawals at ~10%, we anticipate the maximum number of subjects to be consented will be about 200. The MR scans will be carried out within uTSW and Parkland. of these 175 subjects, we anticipate that approximately 30 glioma patients will have interventions (surgery, chemotherapy, and/or radiation) during the enrollment and have MR scans at multiple times points (2 - 4 scans), depending on the clinical need. The study will be performed on 175 subjects at uTSW and Parkland over 3 years.

Subjects will be withdrawn from participation if they are unable to tolerate multiple MRi exams or if a study physician deems participation unfavorable. Participants will understand that withdrawing consent or failure to participate will in no way affect their ability to receive standard-of-care treatment from uTSW providers.

Participant Eligibility

Inclusion criteria for subjects with brain tumors (120 subjects):

* Age > 18 years

* Males and females

* All races and ethnicities

* Patients must meet at least one of the 3 following criteria regarding brain tumor
diagnosis:
- Histological diagnosis of a brain tumor
- Pre-operative brain MR imaging suggestive of a brain tumor
- Radiographic diagnosis of brain tumor in an inoperable location (e.g. brainstem)

* Pretreatment evaluations required for eligibility include a medical history, physical
examination, and neurological exam within 30 days prior to study entry.

* Patient must be able to provide study-specific consent prior to study entry and Health
Insurance Portability and Accountability Act of 1996 (HIPAA) authorization.

* Karnofsky performance status > 70%

* Life expectancy greater than 3 months

Inclusion criteria for subjects with non-tumor neurological disorders (50 subjects):

* Males and females

* All races and ethnicities

* Patients with clinically-proven multiple sclerosis, temporal lobe epilepsy, stroke, or
encephalitis.

Inclusion criteria for healthy volunteers (5 subjects):

* 18 - 40 years of age

* Males and females

* Any ethnic background

* Excellent general health