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Sponsored by: |
University of Utah |
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Information provided by: | University of Utah |
ClinicalTrials.gov Identifier: | NCT00813566 |
The standard treatment approach for patients with high-grade primary brain tumors includes maximum feasible surgical resection, followed by 6 weeks of concurrent cranial irradiation and daily low-dose temozolomide chemotherapy, followed by 12 cycles of high-dose temozolomide administered for 5 consecutive days every 4 weeks [Stupp 2005]. Contrast-enhanced MRI is the current standard for evaluating the success of therapy and monitoring for tumor recurrence. MRI is typically obtained prior to initial surgery, within 24 hours after surgery, at the conclusions of cranial irradiation, and then every 8 weeks during temozolomide chemotherapy until evidence of recurrence. Despite this careful clinical and radiographic surveillance, and despite decades of research into the histologic and molecular classification of primary brain tumors, our ability to predict tumor behavior remains very limited. Some gliomas will result in overall survival times of only months, whereas other histologically-identical gliomas may yield survivals of years to decades [Carson 2007, Curran 1993, Lamborn 2004]. Current assessment of tumor response to therapy is also poor. Patients with complete radiographic response after cranial irradiation often progress rapidly post-irradiation. In contrast, some patients with enhancing masses at the end of chemoradiotherapy may respond dramatically to further chemotherapy alone, or the masses may even disappear in the absence of further therapy (so called "tumor pseudoprogression") [Chamberlain 2007]. This confounding situation demonstrates a need for better assessment of tumor response.
Condition | Intervention |
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Brain Tumors Cancer |
Procedure: FLT PET Imaging |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Multi-Tracer PET Assessment of Primary Brain Tumors |
Estimated Enrollment: | 20 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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Diagnostic |
Procedure: FLT PET Imaging
radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a radiopharmaceutical that directly assess tumor proliferation using Positron Emission Tomography(PET) in differentiating tumor recurrence from radiation necrosis in a group of patients with glial neoplasms.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Study patients: Adult patients (n = 20) with compelling MRI evidence of primary brain tumor that have not yet undergone surgery or any tumor-directed therapy. Four to eight patients per year will be enrolled during the first 3 years, for a total of 20 patients. Enrollment will be weighted toward lower-grade tumors during year 1 in order to allow for longer followup times during the life of the project. Dr. Glantz (Huntsman Cancer Institute Neuro-oncologist) will identify and recruit patients for participation, and obtain informed consent.
Inclusion Criteria:
Such evidence will include: MRI or CT scan-documented mass lesion within the brain, accompanied by anatomically appropriate neurological signs and symptoms, in the absence of a probable competing diagnosis such as brain abscess or primary intracranial hematoma.
Exclusion Criteria:
Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion.
United States, Utah | |
Huntsman Cancer Institute | |
Salt Lake City, Utah, United States, 84112 |
Principal Investigator: | John M Hoffman, MD | Huntsman Cancer Institute |
Study Chair: | Daniel Kadrmas, PhD | Huntsman Cancer Institute |
Responsible Party: | Huntsman Cancer Institute ( John M. Hoffman, MD ) |
Study ID Numbers: | HCI # 31335 |
Study First Received: | December 16, 2008 |
Last Updated: | June 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00813566 History of Changes |
Health Authority: | United States: Food and Drug Administration |
cancer imaging PET scanning |
Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Nervous System Neoplasms |
Brain Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases |
Central Nervous System Diseases Central Nervous System Neoplasms Brain Diseases Nervous System Neoplasms |