Use of Propranolol to Reduce FDG Uptake in Brown Adipose Tissue in Pediatric Cancer Patients PET Scans
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|ClinicalTrials.gov Identifier: NCT02165683|
Recruitment Status : Completed
First Posted : June 17, 2014
Last Update Posted : June 28, 2017
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|Official Title:||Investigation of Propranolol Premedication to Reduce FDG Uptake in Brown Adipose Tissue on PET Scans of Pediatric Cancer Patients|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||October 24, 2016|
|Actual Study Completion Date :||October 24, 2016|
- Number of Adverse Events following Propranolol dosing [ Time Frame: 1 day ]The primary objective of our study will be to document the safety of using a single dose of propranolol.
- Number of Reductions in FDG Uptake in BATWhen Compared to Historic Controls [ Time Frame: 2 years ]We will test the hypothesis that the use of propranolol given prior to the PET scan results in a statistically significant reduction in FDG uptake in BAT compared to historical controls.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02165683
|United States, Kentucky|
|University of Kentucky DanceBlue Pediatric Hematology/Oncology Clinic|
|Lexington, Kentucky, United States, 40536|
|Principal Investigator:||Lars Wagner, MD||University of Kentucky, Dept of Pediatric Hematology/Oncology|