Use of Propranolol to Reduce FDG Uptake in Brown Adipose Tissue in Pediatric Cancer Patients PET Scans

NCT02165683 | Completed DMC

• 1 other identifier: 14-0468-F3r
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric Cancer

Keywords

Cancer; Pediatric; PET Scan

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events following Propranolol dosing

  The primary objective of our study will be to document the safety of using a single dose of propranolol.

  1 day

Secondary Outcomes (1)

• Number of Reductions in FDG Uptake in BATWhen Compared to Historic Controls

  2 years

Eligibility Criteria

• Age: 12 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Individual is between 12 years and 29 years of age
• Individual weighs over 66 pounds
• Individual will be undergoing a FDG-PET scan as part of staging or response assessment for malignancy. Note: the patient may be newly-diagnosed, currently receiving therapy, or have already completed therapy. The presence of identifiable tumor on the PET scan is not required.
• Individual is able to swallow a tablet

You may not qualify if:

• Prior diagnosis of asthma, OR use of an inhaler in past three years to treat or prevent bronchospasm.
• History of cardiac arrhythmia requiring treatment
• History of congestive heart failure
• Current use of medications to control blood pressure or improve cardiac output
• Diabetes Type I or II, or currently on medications to reduce blood sugar
• Pregnant

Sponsors & Collaborators

• Lars Wagner: lead

Study Sites (1)

University of Kentucky DanceBlue Pediatric Hematology/Oncology Clinic

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Lars Wagner, MD

  University of Kentucky, Dept of Pediatric Hematology/Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor/PI

Study Record Dates

• First Submitted: June 13, 2014
• First Posted: June 17, 2014
• Study Start: July 1, 2014
• Primary Completion: October 24, 2016
• Study Completion: October 24, 2016
• Last Updated: June 28, 2017

Record last verified: 2017-06

Locations

US (1)