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Multi-Tracer PET Assessment of Primary Brain Tumors
This study is ongoing, but not recruiting participants.
First Received: December 16, 2008   Last Updated: June 4, 2009   History of Changes
Sponsored by: University of Utah
Information provided by: University of Utah
ClinicalTrials.gov Identifier: NCT00813566
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Rapid, single-scan multi-tracer PET imaging can recover PET imaging biomarker information of each tracer that are not significantly different from those obtained from conventional, single-tracer scans of each tracer. [ Time Frame: December 2012 ] [ Designated as safety issue: No ]
  • Multi-tracer PET biomarkers, obtained in conjunction, are better able to predict tumor aggressiveness than individual-tracer biomarkers or conventional radiographic imaging. [ Time Frame: December 2012 ] [ Designated as safety issue: No ]
  • Multi-tracer PET biomarkers, obtained in conjunction, are better able to detect functional changes in tumor state that occur in response to therapy than individual-tracer biomarkers or conventional radiographic imaging. [ Time Frame: December 2012 ] [ Designated as safety issue: No ]
  • Characterization of multiple aspects of tumor function (glucose metabolism, proliferation, membrane growth, and perfusion) provides new insight into tumor status that can guide selection of the most appropriate therapy. [ Time Frame: December 2012 ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

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
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • Adult patients with compelling evidence of primary brain tumor based on clinical and MRI imaging characteristics that have not yet received surgery, histological diagnosis, or any tumor-directed therapy.

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.

  • Patients must be 18 years or older for inclusion in this study. There is little experience with the safety of [18F]FLT in children, and the risks associated with radiation exposure may be increased for children under 18 years old as well.
  • Karnofsky performance status > 60%.
  • Patients must document their willingness to be followed for at least 24 months after recruitment by signing informed consent documenting their agreement to have clinical endpoints and the results of histopathologic tissue analysis (when tissue becomes available from routine care) entered into a research database.
  • All patients, or their legal guardians, must sign a written informed consent and HIPAA authorization in accordance with institutional guidelines.
  • Determination of pregnancy status: Female patients that are not postmenopausal or surgically sterile will undergo a serum pregnancy test prior to each set of multi-tracer PET scans. A negative test will be necessary for such patients to undergo research PET imaging.
  • Pre-treatment laboratory tests for patients receiving [18F]FLT must be performed within 21 days prior to study entry. These must be less than 2.5 times below or above the upper or lower limit range for the respective laboratory test for entry into the study. In those instances where a baseline laboratory value is outside of this range, then such a patient will be ineligible for enrollment. For the followup scanning sessions after therapy has been instituted, laboratory testing will also be required due to the use of FLT. The patients have brain tumors and will receive various forms of therapy; therefore many routine laboratory tests may not be within the typical normal range. As such, a factor of 4.0x above or below the upper or lower value for the normal range for any laboratory test will be used to determine the acceptable range for the 2nd and 3rd imaging timepoints. The 4.0x value will be critical for liver function test results which can be extremely variable, and a 4.0x above the upper normal range is still acceptable for continued inclusion in this study. The baseline laboratory testing will include liver enzymes (SGOT, SGPT, ALK Phos, GGT, LDH), bilirubin (direct and total), amylase, serum electrolytes, CBC with platelets and absolute neutrophil counts, prothrombin time, partial thromboplastin time, BUN, creatinine, and urinalysis. For the assessments at subsequent imaging time points the urinalysis will not be required however the remainder of the laboratory tests as described for baseline assessment will again be obtained. A negative HIV test will required at baseline. This is due to the previous toxicity of FLT noted in this patient group.

Exclusion Criteria:

  • Patients with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible.
  • Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals.

Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion.

  • Patients who are pregnant or lactating or who suspect they might be pregnant. Serum pregnancy tests will be obtained prior to each set of multi-tracer PET scans in female patients that are not postmenopausal or surgically sterile.
  • Adult patients who require monitored anesthesia for PET scanning.
  • HIV positive patients due to the previous toxicity noted with FLT in this patient group.
  • Patients who have undergone surgery or receive any previous tumor-directed therapy for their brain tumor.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813566

Locations
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: John M Hoffman, MD Huntsman Cancer Institute
Study Chair: Daniel Kadrmas, PhD Huntsman Cancer Institute
  More Information

No publications provided

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

Keywords provided by University of Utah:
cancer
imaging
PET scanning

Study placed in the following topic categories:
Brain Neoplasms
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms

ClinicalTrials.gov processed this record on August 28, 2009