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OpenTrials
Completed

NCT Number: NCT00942760

Protocol to Distinguish Tumor Recurrence From Treatment-Related Necrosis in Patients With High Grade Gliomas

Brain imaging tests are routinely used to detect the presence of a brain tumor or to evaluate the response to treatment. Sometimes the images obtained are not specific and the only way to establish a diagnosis is by obtaining a tissue sample. The hypotheses of the study is to determine if multimodal MR technique will provide tissue signatures that differentiate between tumor progression and treatment related necrosis in high grade glioma patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically proven high grae glioma with central pathology review at DHMC
  • Age 18 equal to or greater than 18 years
  • Karnofsky performance greater or equal to 60%
  • Patients must have received radiation therapy and chemotherapy but should not have received any anti-angiogenesis therapy.

Exclusion criteria

  • Any patient who requires urgent surgical resection of MRI abnormality would not be eligible
  • Pregnant women are not eligible

Treatment and study plan

3T MRI

Device

The introduction of the 3T scanners provides a potential opportunity to improve the quality of imaging in neuro-oncology.

Primary outcomes

  1. To prospectively acquire multiparameter MR variables at 1.5T and 3T MRI from treated high grade glioma patients to assign tissue signatures for tumor recurrence and radiation necrosis as established by pathologic examination.

    Time frame: 24 months

Secondary outcomes

  1. To compare the predictive values of the multiparameter MR tissue signatures acquired at 1.5T and 3T

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

DMS-0901: Multimodal Magnetic Resonance Protocol to Distinguish Tumor Recurrence From Treatment-Related Necrosis in Patients With High Grade Gliomas

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 21, 2009
Registry last updated
May 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.