Pediatric CancerNCT02165683
Use of Propranolol to Reduce FDG Uptake in Brown Adipose Tissue in Pediatric Cancer Patients PET Scans
An observational study of Pediatric Cancer, run by Lars Wagner at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 29 years
- Conditions the study is for
- Pediatric Cancer
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 24 Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky DanceBlue Pediatric Hematology/Oncology Clinic
Lexington, Kentucky, 40536
About this study
Official title: 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.
Read the 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.
- Conditions
- Pediatric Cancer
- Keywords
- Cancer, Pediatric, PET Scan
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (1)
Number of Reductions in FDG Uptake in BATWhen Compared to Historic Controls
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startJul 2014
- Primary completion24 Oct 2016
- Study completion24 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lars Wagner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lars Wagner, University of Kentucky
- Investigators
- Lars Wagner, MD, Principal investigator, University of Kentucky, Dept of Pediatric Hematology/Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165683
- Sponsor's protocol ID
- 14-0468-F3r
- Status last verified
- Jun 2017
- First submitted
- 13 Jun 2014
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Propranolol Premedication to Reduce FDG Uptake in Brown Adipose Tissue on PET Scans of Pediatric Cancer Patients
- ClinicalTrials.gov ID
- NCT02165683
- Acronym / sponsor ID
- 14-0468-F3r
- Conditions
- Pediatric Cancer
- Keywords
- Cancer, Pediatric, PET Scan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Lars WagnerUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 24 Oct 2016 (actual)
- Study completion
- 24 Oct 2016 (actual)
- First posted
- 17 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Number of Reductions in FDG Uptake in BATWhen Compared to Historic Controls
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
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Knowledge, Attitudes, Practice
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Wagner, MD principal investigator
University of Kentucky, Dept of Pediatric Hematology/Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Cancer, run by Lars Wagner at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events following Propranolol dosing (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2017.