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Neuroimaging for Pain in Fibrous Dysplasia

N/A

Waitlist Available

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

10-45 years of age

Diagnosis of Fibrous Dysplasia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 50-60 minutes

Awards & highlights

Study Summary

This trial is investigating what causes pain in adults with Fibrous Dysplasia/McCune-Albright Syndrome.

Who is the study for?

This trial is for English-speaking individuals aged 10-45 with a diagnosis of Fibrous Dysplasia. It's open to both male and female participants, including minors if they have parental assistance for consent.Check my eligibility

What is being tested?

The study uses advanced imaging techniques like MRI-based neuroimaging, non-contrast MRI, and two types of PET/CT scans (18F-NaF and 18F-FDG) to investigate the causes of pain in patients with Fibrous Dysplasia.See study design

What are the potential side effects?

While the interventions are primarily diagnostic imaging procedures that are generally safe, potential side effects may include discomfort during scanning, allergic reactions to tracers used in PET/CT scans, or exposure to low levels of radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 10 and 45 years old.

Select...

I have been diagnosed with Fibrous Dysplasia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 50-60 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~50-60 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 50-60 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

% signal difference in BOLD signal

Secondary outcome measures

Numerical clinical pain rating score

Other outcome measures

18F-FDG or 18F-NaF uptake in FD lesion site

Trial Design

2Treatment groups

Experimental Treatment

Group I: Healthy ControlsExperimental Treatment1 Intervention

20, matched healthy controls

Group II: Fibrous Dysplasia/McCune-Albright SyndromeExperimental Treatment4 Interventions

20, Fibrous Dysplasia/McCune-Albright Syndrome Patients with or without pain

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Non-contrast MRI

2018

N/A

~100

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,548 Total Patients Enrolled

Boston Children's HospitalLead Sponsor

760 Previous Clinical Trials

5,579,640 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any restrictions on who can participate in this research endeavor?

"In order to be enrolled in this study, applicants must meet the criteria of having fibrous dysplasia and being within a 10-45 year age bracket. The team is currently recruiting around 40 people for the trial."

Answered by AI

Are there any current enrollments in this experiment?

"According to the clinicaltrials.gov website, this trial is not admitting new participants at present. Initially posted on May 1st 2021 and last updated September 1st 2021, it is not actively looking for volunteers; however there are six other trials that require recruitment presently."

Answered by AI

Does this medical investigation consider geriatric patients?

"This trial is geared towards individuals between the ages of 10 to 45. Separately, there are 4 trials that cater to patients below 18 and 3 for those over 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pain in Fibrous Dysplasia

Jaymin Upadhyay 2021. "Pain in Fibrous Dysplasia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04125862.