- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01166854
Characterization of Familial Myopathy and Paget Disease of Bone
Phase 1 Study Non-invasive Use Diffuse Optical Spectroscopy Will Measure the Concentrations of Blood, Water, and Lipids (Fats, for Example) in Tissues
The researcher wants to explore the genetic causes of muscle disease. The researcher is particularly interested in muscle disorders that occur in combination with diseases of bone that appear to be passed on from generation to generation.
Diffuse Optical Spectroscopy will measure the concentrations of blood, water, and lipids (fats, for example) in your tissues. This device essentially measures the color of tissues in order to determine tissue physiology (its physical and chemical processes).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Diffuse Optical Spectroscopy, the technique is fast and painless and was developed at the University of California, Irvine. The Diffuse Optical Spectroscopy instrument is actively involved in research studies, but is not yet a part of routine clinical practice. The result of this study will aid similar research projects that seek to improve our understanding of how tissues work and how alterations in metabolism affect long-term health.
TheDiffuse Optical Spectroscopy measurement consists of placing a probe onto the surface of your body (calf, bicep, or head). This probe will be secured by either gentle hand pressure or fastened to your skin using clinically-approved wraps such as Coban/wrap bandages or medical adhesive tape and medical glues. Several dots will be made on your skin outlining the probe with a surgical felt tip marker. This is so we would be able to put the probe again on the same spot in case we needed to interrupt the measurement. The probe looks like a bar code scanner in a supermarket and it shines infrared light on your skin. There is no radiation involved with this light. In some cases where light signals are low, the optical detector will be placed directly onto your skin (but contained within an electronically shielded casing, and placed inside another plastic casing). (not offered during pregnancy).
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Marie Wencel, BS
- Phone Number: 949-824-0521
- Email: mwencel@uci.edu
Study Locations
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California
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Irvine, California, United States, 92612
- Recruiting
- Beckman Laser Institute Medical Clinic
-
Contact:
- Marie Wencel, BS
- Phone Number: 949-824-0521
- Email: mwencel@uci.edu
-
Contact:
- Montana Compton, RN
- Phone Number: 949-824-9265
- Email: mocomton@uci.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria: Male or Female age 18 and older
- diagnose of Muscle or bone disorders
- with a combination of medical problems including muscle and bone disease and their family members.
Exclusion Criteria:
- under 18 year of age
- unrelated diagnosis
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Muscle weakness
Diffuse Optical Spectroscopy
|
Diffuse Optical Spectroscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
muscle disease
Time Frame: 1 week
|
1 week
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Bruce Tromberg, PhD, Beckman Laser Institute University of California Irvine
- Principal Investigator: Virginia Kimonis, MD, Beckman Laser Institute University of California Irvine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIH/LAMMP-2007-5832
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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