Use of Propranolol to Reduce FDG Uptake in Brown Adipose Tissue in Pediatric Cancer Patients PET Scans
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 12 - 29 |
| Updated: | 6/29/2017 |
| Start Date: | July 2014 |
| End Date: | October 24, 2016 |
Investigation of Propranolol Premedication to Reduce FDG Uptake in Brown Adipose Tissue on PET Scans of Pediatric Cancer Patients
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.
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.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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