Image-Based Quantitative Assessment of Acute Radiation-Induced Changes in Glioma

Once eligibility criteria have been assessed and the informed consent is obtained,
participants will undergo a screening process to further ensure eligibility. Screening prior
to registration will comprise a review of pathology reports, postoperative magnetic resonance
Imaging (MRI) images, operative reports, and medical history; general physical and neurologic
exams; routine blood work; and urine pregnancy test for women of childbearing age.

The study is intended to evaluate the response of radiation treatment (RT). The consent
process will be performed between the surgery and the start of RT. RT will be prescribed as
per the discretion of the treating radiation oncologist as per the University of Alabama at
Birmingham Department of Radiation Oncology treatment protocol in combination with
temozolomide.

MRIs will be obtained before start of RT, after completion of 20 +/- 4 Gy. after completion
of 40+/- 4 Gy and after the entire radiation treatment. Conventional MRIs including perfusion
sequences and whole brain spectroscopy will be performed as a part of the research study. The
data obtained from this research studies will not be used for clinical management.

Volumes of the enhancing component, non enhancing component, choline/N-acetyl aspartate
(Cho/NAA) will be measure before, during and after RT as described before. Cerebral blood
volume (CBV) of the tumor will also be calculated from perfusion imaging at each time point.
Apparent diffusion co-efficient (ADC) of the tumor will be calculated from the diffusion
imaging.

All the patients will be followed up with imaging and will be treated as per the standard of
care. Patients will return for clinical evaluation and standard of care imaging approximately
4 weeks from the completion of the radiation therapy. After that, all the patients will be
treated with standard of care maintenance temozolomide therapy and will return every 2-3
months for clinical evaluation and standard of care imaging.

At the time of recurrence, the recurrence site will be assessed and will be compared with the
imaging parameters obtained during radiation treatment. Time to recurrence will also be
calculated and will be correlated with the imaging parameters.

Inclusion Criteria:

1. Newly diagnosed glioma, based on pathology confirmation;

2. At least 8 cm3 of residual enhancing tumor after surgery or significant visible tumor
(As seen on immediate postoperative scan);

3. Scheduled to receive standard fractionated RT with concomitant temozolomide therapy;

4. Karnofsky Performance Score > 60.

Exclusion Criteria:

1. Scheduled to receive investigational chemotherapy, immunotherapy, or any other
investigational agents;

2. Placement of GLIADEL® wafer in the resection cavity;

3. Significant amount of hemorrhage within the resection cavity (seen on immediate
post-operative scan);

4. A large peritumoral infraction related to surgery (identified by new confluent
diffusion restriction);

5. Not suitable to undergo MRI or use the MRI contrast agent (GFR<30 mL/min/1.73 m2); or
the patient has known anaphylactic reaction to gadolinium based contrast agents.

6. Presence of serious systemic illness, including: uncontrolled infection, uncontrolled
malignancy, significant renal disease, or psychiatric/social situations, which might
impact the survival endpoint of the study or limit compliance with study requirements.