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Study on Neuroepithelial Tumor Grading and Pseudoprogression After Glioma Therapy Using Advanced Functional MRI Techniques

Study Purpose

Contrast-enhanced MRI is the most common way for evaluating neuroepithelial tumor grading and monitoring for tumor recurrence,but the ability to predict tumor behavior remains very limited.In this study, the investigators will use multi-b-value diffusion-weighted imaging(DWI),three-dimensional arterial spin labeling(3D-ASL) and dynamic contrast-enhanced MRI imaging(DCE) to evaluate neuroepithelial tumor grading and monitor for tumor recurrence.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Among the patients with high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma), who received concurrent chemoradiation (CCRT) with temozolomide, the patients show the measurable enhancing portion (1 cm in the long diameter according to the RANO criteria) in the immediate f/up MRI after CCRT.

Exclusion Criteria:

- Among the patients with high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma), who received concurrent chemoradiation (CCRT) with temozolomide, the patients do not show the measurable enhancing portion (1 cm in the long diameter according to the RANO criteria) in the immediate f/up MRI after CCRT.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02622620
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Tang-Du Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Unknown status
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma, Neoplasms

Additional Details

Glioma is classified into 4 grades, with worse prognosis for more advanced grades.Previous studies have suggested that different therapeutic strategies should be applied for gliomas at different grades,so glioma grading before the operation is therefore of important clinical significance for guiding the grade-dependent therapeutic strategy. Combination temozolomide and radiation significantly prolongs survival compared with radiation alone and has become standard treatment for Patients with high-grade glioma. Response assessment in these patients is difficult as a result of the frequent occurrence of early imaging changes indistinguishable from tumor progression, termed pseudoprogression. The majority of patients remain clinically stable. It is often unclear whether current therapy should be maintained or second-line therapy initiated. The ADC value can potentially reveal the differences in cellularity and nuclear atypia of gliomas1. Theoretically, high cellularity in advanced gliomas may impede free water diffusion and thus lead to a decreased ADC value.In several previous studies,recurrent tumors have shows significantly higher cellularity than those shown by pseudoprogression.Such high cellularity is associated with relative reductions in extracellular space when compared with low cellularity, resulting in decreased diffusivity of water molecules in the former circumstance when compared with the latter. DWI measures the degree of water diffusion within tissue Apparent diffusion coefficient (ADC) values quantify the mobility of water molecules at the cellular level, holding the potential to differentiate between necrosis, edema and recurrent tumor. A potential mechanism of pseudoprogression is that radiation-induced vascular changes may lead to focal transient increase in gadolinium enhancement.Three-dimensional arterial spin labeling(3D-ASL) and dynamic contrast-enhanced (DCE) MRI imaging provides a noninvasive means for quantifying tumor vascular properties.

Arms & Interventions

Arms

: Patients with glioma

Patients with high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma), who receive concurrent chemoradiation (CCRT) with temozolomide

Interventions

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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