MRI and PET/FMISO In Assessing Tumor Hypoxia in Patients With Newly Diagnosed Glioblastoma Multiforme
Condition: Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma
MeSH terms: Glioblastoma; Gliosarcoma; Hypoxia
Intervention: FMISO; MRI; PET; MRS
Intervention description: FMISO PET scans; Undergo MRI; Undergo FMISO PET scan
Intervention MeSH terms: Misonidazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well positron emission tomography (PET) scan using
      18F-fluoromisonidazole works when given together with magnetic resonance imaging (MRI) ) in
      assessing tumor hypoxia in patients with newly diagnosed glioblastoma multiforme (GBM).
      Diagnostic procedures, such as MRI and PET scan using 18F-fluoromisonidazole (FMISO), may
      help predict the response of the tumor to the treatment and allow doctors to plan better
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be able to provide a written informed consent

          -  Newly diagnosed glioblastoma multiforme (GBM), World Health Organization (WHO) grade
             IV based on pathology confirmation

          -  Residual tumor after surgery (amount of residual tumor will not impact patient
             eligibility and visible residual disease can include T2/FLAIR hyperintensity)

               -  Note: If patient had a biopsy only, postoperative MRI is not needed to assess
                  residual tumor prior to enrollment

          -  Scheduled to receive standard fractionated radiation therapy

          -  Scheduled to receive Temozolomide (TMZ) in addition to radiation therapy

          -  Karnofsky Performance Score > 60

        Exclusion Criteria:

          -  Pregnant or breastfeeding (if a female is of child-bearing potential, and unsure of
             pregnancy status, a standard urine pregnancy test should be done)

          -  Scheduled to receive chemotherapy, immunotherapy, or investigational agents in trials
             unwilling to share data with ACRIN (i.e., additional therapy added to radiation and
             TMZ is allowed if ACRIN is able to obtain treatment information)

          -  Not suitable to undergo MRI or use the contrast agent Gd because of:

          -  Claustrophobia

          -  Presence of metallic objects or implanted medical devices in 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 implants)

          -  Sickle cell disease

          -  Renal failure

          -  Reduced renal function, as determined by Glomerular Filtration Rate (GFR) < 30
             mL/min/1.73 m^2 based on a serum creatinine level obtained within 28 days prior to
             registration

          -  Presence of any other co-existing condition which, in the judgment of the
             investigator, might increase the risk to the subject

          -  Presence of serious systemic illness, including: uncontrolled intercurrent infection,
             uncontrolled malignancy, significant renal disease, or psychiatric/social situations
             which might impact the survival endpoint of the study or limit compliance with study
             requirements

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to FMISO; an allergic reaction to nitroimidazoles is highly unlikely

          -  Not suitable to undergo PET or MRI, including weight greater than 350 lbs (the weight
             limit for the MRI and PET table)

          -  Prior treatment with implanted radiotherapy or chemotherapy sources such as wafers of
             polifeprosan 20 with carmustine