Use of Propranolol to Reduce FDG Uptake in Brown Adipose Tissue in Pediatric Cancer Patients PET Scans
Condition: Pediatric Cancer
Study type: Observational

Summary: 
      This is a single-arm, open-label study to assess the safety and effectiveness of a single
      dose of oral propranolol in reducing18F-fluorodeoxyglucose (FDG) uptake in brown adipose
      tissue (BAT) in pediatric oncology patients. This study is designed to better understand if
      taking a single dose of an oral medication called propranolol can reduce the chance of brown
      fat showing up on a PET scan, and therefore make the scan more accurate and easy to
      interpret. All humans have some degree of normal brown fat (called brown adipose tissue), and
      this normal tissue can sometimes light up on a PET scan. That creates problems because it may
      be wrongly interpreted by the radiologist as tumor, or it may hide true areas of tumor
      underneath it. Participants will not be randomized and will receive a single dose of oral
      propranolol approximately 60 minutes prior to the injection of the FDG tracer. The dose of
      propranolol will be 20 mg for all participants.
    

Detailed description: 
      In this study, participants will be assessed in the University of Kentucky DanceBlue
      Pediatric Hematology/Oncology clinic to confirm they are eligible for the study. This will be
      done at the time intravenous (iv) access is started, either through an iv placed in the arm
      or through a port/central line.

      All females who are capable of becoming pregnant will then undergo urine pregnancy testing.
      If it is found that they are pregnant they will not be allowed to be in the study.
      Participant blood sugar will be checked. When possible, the research blood sample will be
      collected at a time when routine non-research labs will be collected.

      Study eligible participants will then be given a single 20 mg tablet of propranolol to take
      by mouth and will be escorted by a member of the medical team to the PET scan trailer, where
      they will be checked in and assessed. Blood sugar level will again be checked by finger stick
      according to the standard procedure for PET scans.

      Vital signs will be assessed by a clinical research nurse at least three times while the
      participants are at the PET scan trailer, including twice before the scan and once
      immediately after the scan. The nurse will also assess for any symptoms related to the
      propranolol. If no problems are noted, participants will be discharged from the PET scan
      trailer and their tudy participation will end. If any side effects arise from the medication,
      the pediatric oncologist will be called immediately and appropriate treatment started. The
      PET scan will be assessed by the radiologist to see whether there is uptake in brown fat, as
      well as to see if any areas of tumor are seen.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        11 Male and female participants from all races and ethnic backgrouns who are receiving
        treatment by the University of Kentucky Medical Center, Pediatric Oncology divsion.
      
Keywords: Cancer; Pediatric; PET Scan