Multi-tracer PET in Imaging Patients with Brain Tumors

Status: Active

Description

This pilot clinical trial studies multi-tracer positron emission tomography (PET) in imaging patients with brain tumors. PET uses radioactive labels (tracer), such as fludeoxyglucose F 18 (18F-FDG), fluorine F 18 fluorothymidine (18F-FLT), carbon 11 acetate (11C-ACE), or oxygen 15 water (15O-H2O), which can recognize differences between tumor and healthy brain. Multi-tracer PET may help find tumor proliferation (movement), glucose metabolism (sugars), blood flow, and growth rate in order to better predict treatment response.

Eligibility Criteria

Inclusion Criteria

  • Three different adult patient groups will be eligible for inclusion in this study: * Group 1: Adult patients with compelling evidence of primary brain tumor based on clinical and magnetic resonance imaging (MRI) or computed tomography (CT) 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 * Group 2: Newly diagnosed primary malignant brain tumors (World Health Organization [WHO] grade II-IV glial-based tumors) who have not had a complete surgical resection and by contrast MRI or CT have residual tumor >= 1.0 cm in diameter and will be receiving radiotherapy and/or chemotherapy * Group 3: Patients with probable or possible recurrent primary brain tumor as determined by standard clinical criteria or MRI or CT imaging; the abnormality must be >= 1.0 cm in diameter by contrast MRI or CT or show changes on non-enhancing MRI sequences (T2 or fluid-attenuated inversion recovery [FLAIR])
  • 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 Health Insurance Portability and Accountability Act (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 4.0 times below or above the upper or lower limit range for the respective laboratory test for entry into the study (unless clinically not relevant); in those instances where a baseline laboratory value is outside of this range, then such a patient will be ineligible for enrollment; for the follow-up 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 have received various forms of therapy; therefore, many routine laboratory tests may not be within the typical normal range; as such, a factor of 4.0 times above or below the upper or lower value for the normal range for any laboratory test will also be used to determine the acceptable range for the 2nd and possible 3rd imaging time points (unless clinically not relevant); the baseline laboratory testing will include liver enzymes (alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALK], lactate dehydrogenase [LDH]), bilirubin (total), serum electrolytes, complete blood count (CBC) with platelets and, prothrombin time, partial thromboplastin time, blood urea nitrogen (BUN), creatinine; previous urinalysis abnormalities will not preclude the patient from being studied; for those patients receiving Coumadin or another anticoagulant the upper limit for prothrombin time or partial thromboplastin time must not exceed 6 times the upper limit of the normal range

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
  • Known human immunodeficiency virus (HIV) positive patients

Locations & Contacts

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Contact: John M. Hoffman
Phone: 801-587-4064
Email: john.hoffman@hci.utah.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To implement and evaluate a new imaging technology for rapid, single-scan multi-tracer PET imaging of these tracers.

SECONDARY OBJECTIVES:

I. To preliminarily evaluate the complementary value of FDG, FLT, ACE, and H2O PET in patients with primary glial neoplasms.

OUTLINE:

Patients undergo 18F-FDG PET, 18F-FLT PET, 11C-ACE PET, and 15O-H2O PET scans prior to surgery or immediately after surgery (baseline), at the conclusion of initial chemoradiotherapy (approximately 6-8 weeks), and at the time of documented recurrence within 2 years. Patients undergo separate single-tracer scans with each tracer over 2 days during Phase A. During Phase B, patients undergo PET imaging with two or more tracers in a single scan.

After completion of study, patients are followed up for at least 12 months.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Diagnostic

Lead Organization

Lead Organization
Huntsman Cancer Institute / University of Utah

Principal Investigator
John M. Hoffman

Trial IDs

Primary ID HCI31335
Secondary IDs NCI-2014-01824, 31335
Clinicaltrials.gov ID NCT00813566