Clinical Trial Details
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NCT00902577 : MRI and PET Scan Using 18F-Fluoromisonidazole In Assessing Tumor Hypoxia in Patients With Newly Diagnosed Glioblastoma Multiforme
PhasePhase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Pathologically confirmed glioblastoma multiforme

- Newly diagnosed disease

- Grade IV according to WHO criteria

- Residual tumor required after surgery, including T2/FLAIR hyperintensity

- Amount of residual tumor will not impact patient eligibility

- Scheduled to receive standard fractionated radiation therapy and temozolomide

- May also receive an anti-VEGF or PARP-inhibiting therapy

- Karnofsky performance status 60-100%

- Not pregnant or nursing

- Negative pregnancy test

- Able to undergo MRI and use gadolinium-contrast agent, meeting the following

- No claustrophobia

- No metallic objects or implanted medical devices in the body (i.e., cardiac
pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves
with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel

- No sickle cell disease

- No renal failure

- No reduced renal function, as determined by glomerular filtration rate < 30
mL/min based on a serum creatinine level obtained within 28 days prior to study

- No other concurrent condition that, in the judgment of the investigator, might
increase patient's risk

- No concurrent serious systemic illness, including any of the following:

- Uncontrolled intercurrent infection

- Uncontrolled malignancy

- Significant renal disease

- Psychiatric or social situations that might impact the survival endpoint of the
study or limit compliance with study requirements

- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to FMISO

- Able to undergo PET or MRI (i.e., weight ? 350 lbs)

- Able to tolerate 100% oxygen < 10 minutes (e.g., no history of chronic obstructive
pulmonary disease)

- No prior implanted radiotherapy or chemotherapy sources (i.e., wafers of polifeprosan
20 with carmustine)

- Not scheduled to receive chemotherapy, immunotherapy, or biologic agent other than
temozolomide, including any anti-tumor investigational agent

- Concurrent anti-VEGF agent allowed
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