Status:
COMPLETED
Pain in Fibrous Dysplasia
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Fibrous Dysplasia/McCune-Albright Syndrome
Eligibility:
All Genders
10-45 years
Phase:
NA
Brief Summary
Pain remains a common and frequently debilitating symptom, particularly during adulthood of Fibrous Dysplasia/McCune-Albright Syndrome (FD/MAS). For many FD/MAS patients, the amount of pain perceived ...
Detailed Description
In Fibrous Dysplasia/McCune-Albright Syndrome (FD/MAS), healthy bone tissue and marrow is replaced with pre-osteoblastic, fibrous tissue, yielding skeletal deformities and an increased propensity towa...
Eligibility Criteria
Inclusion
- Inclusion Criteria (FD/MAS patients):
- Male and Female subjects
- 10-45 years of age
- English Speaking ability sufficient to comprehend consent (with parental assistance if minor)
- Diagnosis of Fibrous Dysplasia
- Exclusion Criteria for patients:
- Younger than 10 or older than 45 years old
- Weight \> 285 lbs (weight limit of the MRI table and \< 36lbs)
- Surgery leaving implanted material
- Contraindications to MRI scanning and PET scanning (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia, previous significant research related exposure to ionizing radiation)
- Exclusion Criteria for healthy controls:
- Same as for the patients, with the addition of the following:
- • Use of recreational or illicit drugs History of chronic pain
Exclusion
Key Trial Info
Start Date :
January 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04125862
Start Date
January 5 2021
End Date
December 1 2025
Last Update
December 11 2025
Active Locations (1)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115