CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
Whole Body PET Baseline with 11C Rolipram +2 moredrug
Likely dose
Whole Body PET Blocked with Roflumilast 500 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02743377
NCT02743377Phase 2Completed

PET Imaging of Phosphodiesterase-4 (PDE4) in Brain and Peripheral Organs of Mccune-Albright Syndrome

National Institute of Mental Health (NIMH)·interventional·Posted Apr 19, 2016·Updated Oct 19, 2020

In Brief

A Phase 2 clinical trial evaluating Brain PET Imaging with 11C Rolipram, Whole Body PET Baseline with 11C Rolipram, and 1 other intervention for Nervous System Disease. Completed, enrolled 16 participants across 1 site.

Detailed Summary

Background: McCune-Albright Syndrome (MAS) is a disorder that affects the bones, skin, and some hormone-producing tissues. It is associated with a mutation in a gene. This gene affects enzymes in the brain and body. Researchers want to learn more about one of these enzymes, Phosphodiesterase 4 (PDE4), in people with MAS. Objective: To see if people with MAS have higher levels of PDE4 than people without MAS. Eligibility: People ages 18 and older who have MAS and participated in protocol 98-D-0145, Screening and Natural History of Patients with Polyostotic Fibrous Dysplasia and the McCune-Albright Syndrome. Healthy adult volunteers are also needed. Design: This study requires 1 to 4 outpatient visits to the NIH Clinical Center. Some visits may take place on the same day. Participants with MAS will be screened with medical history and physical exam. They will have blood and urine tests. Participants will have a magnetic resonance imaging scan. Participants will have a full body positron emission tomography (PET) scan. A small amount of a radioactive chemical, \[11C\](R)-rolipram, will be given through an intravenous tube. Participants will have a brain PET scan with \[11C\](R)-rolipram. For this, a thin plastic tube will also be put into an artery at their wrist or elbow crease area. For the scans, participants will lie on a bed that slides in and out of a scanner. They may wear a plastic mask to hold their head in place. They will have blood drawn. Participants with MAS will be interviewed about their thinking and mood. They may complete questionnaires about how they feel or think.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 19, 2016
Enrollment StartApr 4, 2018
Primary CompletionOct 23, 2019
Study CompletionMay 19, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.2 years ago

Interventions

Brain PET Imaging with 11C Rolipramother

Brain PET Imaging, single scan, with 11C Rolipram 20 mCi given intravenously at the start of the scan

Whole Body PET Baseline with 11C Rolipramdrug

Whole Body Baseline PET Imaging, single scan, with 11C Rolipram 20 mCi given intravenously at the start of the scan

Whole Body PET Blocked with Roflumilastdrug

Whole Body PET Imaging scan after blockade with Roflumilast 500 mcg PO, given 1-2 hours prior to start of scan