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Laser-based Photoacoustic Tomography of Human Inflammatory Arthritis

Study Purpose

The purpose of this feasibility study is to determine if a new emerging technology called photoacoustic tomography (PAT) can be adapted for use in humans for the detection of chronic rheumatoid arthritis.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Men and women 18 years of age or older can participate in this study.
  • - Patients can participate in this study if they have had rheumatoid arthritis for more than 2 years and their rheumatologist has referred them to this study.
  • - Patients can participate as a healthy volunteer with a known history of rheumatoid arthritis.

Exclusion Criteria:

  • - Patients, who have electrically, magnetically or mechanically activated implants such as heart pacemaker, magnetic surgical clips, prostheses or implanted neurological stimulator.
  • - Pregnant patients.
  • - Patients who is claustrophobic.
  • - Patients with impaired renal function cannot participate in this study such as elevate creatinine clearance, patients on kidney dialysis etc. - Patients with shock hypotension or unstable low blood pressure.
  • - Patients with Rhabdomyolysis.
  • - Patients who have had a contrast enhanced (with gadolinium) MRA (magnetic resonance angiography)/ or MRI within the last 3 months.
(Contrast is a medication injected into a vein during a imaging examination that helps produce clearer images/pictures).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00748254
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Michigan
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Xueding Wang, Ph.D
Principal Investigator Affiliation University of Michigan
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Arthritis, Rheumatoid
Additional Details

The objective of this proposal is to adapt photoacoustic tomography (PAT), a novel, nonionizing, noninvasive, laser-based technology, for structural and functional imaging of human peripheral joints affected by inflammatory arthritis. Combining the advantages of both light and ultrasound scanning, PAT holds promise to present objective optical information in subsurface joint tissues with high sensitivity and high spatial resolution. This could be of considerable help in the early detection of inflammatory joint diseases. PAT may also prove useful in further understanding the pathophysiology of these disorders and assisting with therapeutic decisions, including assessment of new pharmacological therapies.

Arms & Interventions

Arms

: Rheumatoid Arthritis

Patients who have active disease affecting the joints in the hand will have Laser Based Photoacoustic Tomography (PAT), MRI, Ultrasound

: Normal controls

Healthy volunteers who do not have arthritis will also have Laser Based Photoacoustic Tomography (PAT), MRI, Ultrasound on the joints of their hand

Interventions

Procedure: - Laser Based Photoacoustic Tomography, MRI, Ultrasound

Healthy subjects will have scans on finger joints with any of the scanning methods described above.

Procedure: - laser based photoacoustic tomography, MRI, ultrasound

Subjects with arthritis will have scans on finger joints with any of the scanning methods described above.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Universtity of Michigan Health System, Ann Arbor, Michigan

Status

Recruiting

Address

Universtity of Michigan Health System

Ann Arbor, Michigan, 48109

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