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

Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03168919
• Other study ID #: F160324004
• Status: Terminated
• Phase: N/A
• Start date: October 6, 2016
• Est. completion date: June 12, 2018

Study information

• Verified date: September 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: June 12, 2018
• Est. primary completion date: June 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioma

Intervention

Radiation:
• Fractionated Radiation
Standard of care fractionated radiation therapy will be given to the tumor.

Drug:
• Temozolomide
Standard of care temozolomide will be given along with radiation therapy

Device:
• MRI
Four MRI scan will be performed according to the protocol. The first one will be obtained before start of radiation therapy, the second MRI will be obtained after completion of 20 +/- 4 Gy, the third MRI will be obtained after completion of 40 +/- 4 Gy, and the final MRI will be obtained after completion of the radiation therapy.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to Progression	Percentage change of the Cho/NAA, ADC and nCBV from baseline to the end of radiation therapy, RT will be used for assessment of time to progression.	From Baseline through 24 months.
Primary	Number of Participants With the Changes of the Chemical Environment of the Tumor	Multiple MRI techniques will be used to assess chemical environment (Cho/NAA) of the tumor during the course of fractionated radiation treatment.	From Baseline to 6 weeks.
Secondary	Changes of Tumor Cellularity	Diffusion MRI will be used for assessment of measures tumor cellularity (with minimum apparent diffusion co-efficent, ADC) during the course of fractionated radiation treatment.	From baseline to 6 weeks
Secondary	Changes of Tumor Volume	MRI will be used for assessment of measures tumor volume.	From baseline Up to 6 weeks
Secondary	Changes of Tumor Angiogenesis	Perfusion MRI will be used for assessment of tumor angiogenesis (with median normalized cerbral blood volume, nCBV) during the course of fractionated radiation treatment.	From baseline to 6 weeks