Pain in Fibrous Dysplasia
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04125862 |
Recruitment Status :
Enrolling by invitation
First Posted : October 14, 2019
Last Update Posted : September 2, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fibrous Dysplasia/McCune-Albright Syndrome | Diagnostic Test: MRI-based Neuroimaging Diagnostic Test: Non-contrast MRI Diagnostic Test: 18F-FDG-PET/CT Diagnostic Test: 18F-NaF-PET/CT | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 2 parallel cohorts (FD/MAS patients and matched, healthy controls) |
Masking: | Single (Participant) |
Masking Description: | Individual performing data analyses will be blinded to whether dataset corresponds to FD/MAS patient or matched healthy control |
Primary Purpose: | Basic Science |
Official Title: | Elucidating Mechanisms of Pain in Adolescent and Adult Fibrous Dysplasia Patients |
Actual Study Start Date : | January 5, 2021 |
Estimated Primary Completion Date : | November 1, 2022 |
Estimated Study Completion Date : | December 31, 2022 |

Arm | Intervention/treatment |
---|---|
Fibrous Dysplasia/McCune-Albright Syndrome
20, Fibrous Dysplasia/McCune-Albright Syndrome Patients with or without pain
|
Diagnostic Test: MRI-based Neuroimaging
During evoked pain fMRI, noxious pressure and heat stimuli will be applied in the two anatomical sites noted above. During fMRI data acquisition, a total of 5 pressure stimulations and 5 heat stimulations will be delivered. Both types of pain stimuli will be applied in a 36/17-sec off/on cycle. The off-condition will correspond to a baseline temperature of 35C and the on condition will match the subject-specific and site-specific 7/10 pressure and heat pain thresholds defined during QST procedures. VAS pain ratings associated with evoked pain stimulation will be collected at the end of each scan. The investigators will also explore the structural properties of the CNS by implementing high-resolution anatomical MRI (gray matter volumes) and diffusion tensor imaging (white matter pathway integrity). All CNS imaging will take approximately 50-60 minutes to complete Diagnostic Test: Non-contrast MRI Musculoskeletal imaging of the affected lower extremity. Patients will be allowed to watch a movie during data acquisition. The following MRI procedures will be completed in order to identify soft tissue lesions in active or painful regions. Fast spin echo (FSE) T2 fat saturated, T1 weighted MRI, FSE proton density MRI, Short-TI Inversion Recovery (STIR), Diffusion weighted MRI (DW-MRI) and 3D Double Echo Steady State (DESS) will be collected. All musculoskeletal MRI will take approximately 30 minutes to complete. Diagnostic Test: 18F-FDG-PET/CT Data will be collected 30 min after the intravenous administration of 18F-FDG with an expected average dose of approximately 200 MBq. CT data will be collected at a low-dose to minimize radiation exposure. Patients will be positioned supine head-first with arms on the side. The investigators project whole body data to be collected, but in some cases, the field of view may be limited to the patient's skull to below the knees. The data acquisition period is expected to last between 15-30 minutes and total radiation dose will be ~3-4 mSv. Diagnostic Test: 18F-NaF-PET/CT Data will be collected 30 min after the intravenous administration of 18F-NaF with an expected average dose of approximately 200 MBq. CT data will be collected at a low-dose to minimize radiation exposure. Patients will be positioned supine head-first with arms on the side. The investigators project whole body data to be collected, but in some cases, the field of view may be limited to the patient's skull to below the knees. The data acquisition period is expected to last between 15-30 minutes and total radiation dose will be ~3-4 mSv. |
Healthy Controls
20, matched healthy controls
|
Diagnostic Test: MRI-based Neuroimaging
During evoked pain fMRI, noxious pressure and heat stimuli will be applied in the two anatomical sites noted above. During fMRI data acquisition, a total of 5 pressure stimulations and 5 heat stimulations will be delivered. Both types of pain stimuli will be applied in a 36/17-sec off/on cycle. The off-condition will correspond to a baseline temperature of 35C and the on condition will match the subject-specific and site-specific 7/10 pressure and heat pain thresholds defined during QST procedures. VAS pain ratings associated with evoked pain stimulation will be collected at the end of each scan. The investigators will also explore the structural properties of the CNS by implementing high-resolution anatomical MRI (gray matter volumes) and diffusion tensor imaging (white matter pathway integrity). All CNS imaging will take approximately 50-60 minutes to complete |
- % signal difference in BOLD signal [ Time Frame: 50-60 Minutes ]• % signal difference within striatal and limbic network structures during evoked-heat pain fMRI between FD/MAS patients with pain, FD/MAS patients without pain and matched, healthy volunteers.
- Numerical clinical pain rating score [ Time Frame: 8 weeks ]• Numerical clinical pain rating score (NPRS, 0-10 scale) at weeks 0, 1, 4 and 8.
- 18F-FDG or 18F-NaF uptake in FD lesion site [ Time Frame: 15-30 Minutes ]18F-FDG or 18F-NaF Standard uptake value ratio in FD lesion site

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 10 Years to 45 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04125862
United States, Massachusetts | |
Boston Children's Hospital | |
Boston, Massachusetts, United States, 02115 |
Responsible Party: | Jaymin Upadhyay, Assistant Professor, BCH, Boston Children's Hospital |
ClinicalTrials.gov Identifier: | NCT04125862 |
Other Study ID Numbers: |
P00030755 |
First Posted: | October 14, 2019 Key Record Dates |
Last Update Posted: | September 2, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | A two-way material transfer agreement has been executed between collaborating parties (Boston Children's Hospital and NIH) |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
Time Frame: | Individual data will start to become available 12/2019 and last for 1.5 years. |
Access Criteria: | A two-way material transfer agreement |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Fibrous Dysplasia of Bone Fibrous Dysplasia, Polyostotic Osteochondrodysplasias Bone Diseases, Developmental Bone Diseases |
Musculoskeletal Diseases Fluorodeoxyglucose F18 Radiopharmaceuticals Molecular Mechanisms of Pharmacological Action |