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Early Detection of Glioblastoma Multiforme (GBM) Treatment Responses Using Multiple Magnetic Resonance Modalities

Study Purpose

The purpose of this study is to determine whether dynamic contrast enhanced MRI (DCE MRI) and high diffusion weighting MRI may be used to distinguish between favorable and unfavorable responses to therapy of glioblastoma multiforme. Imaging data will be correlated with histopathologic findings and clinical responses to radiation therapy with or without chemotherapy.

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 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - The presence of a primary brain tumor that cannot be completely resected that requires radiation therapy with or without chemotherapy.

Exclusion Criteria:

- Patients who do not have a primary brain tumor or who are unable to tolerate the environment of the MRI scanner

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.

NCT00589095
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.

Yale University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jonathan Knisely, M.D.
Principal Investigator Affiliation Yale University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Terminated
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma Multiforme
Arms & Interventions

Arms

: 1

Interventions

Other: - dynamic contrast enhanced magnetic resonance imaging

dynamic contrast enhanced MRI using contrast agent gadodiamide

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Yale University School of Medicine, New Haven, Connecticut

Status

Address

Yale University School of Medicine

New Haven, Connecticut, 06520