Laser-based Photoacoustic Tomography of Human Inflammatory Arthritis

Arthritis, Rheumatoid Clinical Trial

Official title:

Laser-based Photoacoustic Tomography of Human Inflammatory Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00748254
• Other study ID #: HUM00003693
• Secondary ID: R01AR060350
• Status: Recruiting
• Start date: December 1, 2011
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: University of Michigan
• Contact: Safa Mohamed
• Phone: 734 615-1646
• Email: safam[@]med.umich.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 177
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Procedure:
• Laser Based Photoacoustic Tomography, MRI, Ultrasound
Healthy subjects will have scans on finger joints with any of the scanning methods described above.
• laser based photoacoustic tomography, MRI, ultrasound
Subjects with arthritis will have scans on finger joints with any of the scanning methods described above.

Locations

Country	Name	City	State
United States	Universtity of Michigan Health System	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Photoacoustic Imaging	To determine if photoacoustic imaging (PAT) can accurately assist in the diagnosis of chronic rheumatoid arthritis, with data collected every 2 weeks for a maximum of 10 weeks.	10 weeks