Clinical trial NCT03168919: Image-Based Quantitative Assessment of Acute Radiation-Induced Changes in Glioma
Official title: Image-Based Quantitative Assessment of Acute Radiation-Induced Changes in Glioma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Glioma
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One arm study
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants With the Changes of the Chemical Environment of the Tumor
timeFrame: From Baseline to 6 weeks.
Secondary outcomes:
measure: Changes of Tumor Cellularity
timeFrame: From baseline to 6 weeks
measure: Changes of Tumor Volume
timeFrame: From baseline Up to 6 weeks
measure: Changes of Tumor Angiogenesis
timeFrame: From baseline to 6 weeks
Other outcomes:
measure: Time to Progression
timeFrame: From Baseline through 24 months.
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Asim Bag, MD
role: PRINCIPAL_INVESTIGATOR
References: