Status:
TERMINATED
MRI Scans in Evaluating the Effects of Radiation Therapy and Chemotherapy in Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Glioma
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
RATIONALE: Diagnostic procedures, such as MRI, may help in learning how well radiation therapy and chemotherapy work in killing tumor cells and allow doctors to plan better treatment. PURPOSE: This c...
Detailed Description
OBJECTIVES: Primary * To quantitatively compare the relative cerebral blood volume/flow, mean transit time, and mean vessel diameter as measured by perfusion-weighted MRI before, during, and after c...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Newly diagnosed anaplastic glioma (WHO grade III) or glioblastoma multiforme (WHO grade IV)
- Measurable disease
- Residual tumor size after surgery ≥ 1 cm in one dimension
- Planning to undergo standard chemoradiotherapy with temozolomide
- PATIENT CHARACTERISTICS:
- Glomerular filtration rate ≥ 60 mL/min
- Mini Mental Status Exam score \> 15
- Sufficiently competent to give informed consent
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 2 months after completion of study treatment
- No contraindication to MRI or to use of the contrast agent gadolinium, including any of the following:
- Claustrophobia
- Metallic objects or implanted medical devices (e.g., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)
- Sickle cell disease
- Renal failure
- High risk for kidney disease (e.g., age \> 60 years, diabetes, or history of systemic lupus erythematosus or multiple myeloma)
- No known history of chronic obstructive pulmonary disease or emphysema
- No other co-existing condition that, in the judgement of the investigator, may increase risk to the patient
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Non-VEGF investigational agent allowed
- No concurrent chemotherapy (other than temozolomide)
- No concurrent electron, proton, particle, or implant radiotherapy
- No concurrent stereotactic radiosurgery
- No concurrent anti-VEGF anti-tumor agents
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00756106
Start Date
July 1 2008
End Date
February 1 2012
Last Update
May 13 2020
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114