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

• Status: Terminated
• Trial end date: 2018-06-12
• Target enrollment: 0
• Participant gender: All

Summary

The overall goal of this study is to determine if quantitative imaging techniques can be used to detect dynamic changes of morphology and different physiologic properties of the tumor during and after completion of radiation treatment and to predict site and time of radiation.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Temozolomide

Criteria

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.