MedTrace Logo

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

NCT02743377 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-10-19

Study results available
· View outcomes & findings →

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.

Conditions

  • Nervous System Disease

Interventions

OTHER

Brain PET Imaging with 11C Rolipram

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

DRUG

Whole Body PET Baseline with 11C Rolipram

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

DRUG

Whole Body PET Blocked with Roflumilast

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

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    lead NIH

Principal Investigators

  • Robert B Innis, M.D. · National Institute of Mental Health (NIMH)

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-04
Primary Completion
2019-10-23
Completion
2020-05-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02743377 on ClinicalTrials.gov