Subjects in the developmental arm will have a minimum of two study visits to determine the optimal conditions for visualizing lymphatic transport in the upper extremities. Concentrations of 0.1 mg/ml of Indocyanine Green (ICG) will be injected intradermally into the web spaces of the hands in both upper extremities. Multispectral video and still images will be recorded using the MultiSpectral Imaging System (MSImager). An ultrasound of the upper extremities may be performed after the ICG fluorescence is observed. The exam will help identify the location of the lymphatic vessels and nodes in the areas fluoresced.

Subjects in the clearance arm will have an initial study visit that involves injections of 0.1 mg/ml of Indocyanine Green (ICG) intradermally into the web spaces of the hands in both upper extremities. Multispectral video and still images will be recorded using the MultiSpectral Imaging System (MSImager). Follow up imaging sessions will occur weekly for three weeks for a minimum of four study visits total.

Rheumatoid Arthritis

A trained physician will inject 0.1 ml of Indocyanine Green into the web spaces of the hands in both upper extremities. Subjects may have up to five study visits to confirm feasibility, safety, and reproducibility.

Indocyanine Green

Once the Indocyanine Green is injected, the contrast is expected to fluoresce underneath the MultiSpectral Imaging System. Multispectral video and still images will be recorded at the study visits.

MultiSpectral Imaging System

Allergy, Immunology, and Rheumatology Clinical Trials

University of Rochester

NIR Fluorescence Imaging of Lymphatic Transport Using ICG

Near InfraRed Fluorescence Imaging of Lymphatic Transport Using Indocyanine Green

The contraction rate is measured as lymphatic vessel contractions/min in the dominant lymphatic vessel efferent to the injection site using the MultiSpectral Imaging System (MSImager) that captures real time movies. The MSImager software analyses the signal intensity to determine the contraction rate.

The lymphatic pressure is measured using a transparent cuff and the Multispectral Imaging System to determine indirect lymphatic pressure and recorded as mm Hg.

The change in Indocyanine Green signal intensity (arbitrary units) over time is measured by observing the fluorescence using the Multispectral Imaging System. The MSImager software analyses the signal intensity.

Speed with which an Indocyanine Green bolus moves through a lymphatic vessel recorded as mm -sec-1 using the Multispectral Imaging System. The MSImager software analyses the signal speed.

Information of any type may be shared with researchers at other institutions. Subjects will be made aware of this in the informed consent form.

Christopher Ritchlin

M.D., M.P.H.; Professor of Medicine, Chief of Allergy, Immunology & Rheumatology Division

National Institutes of Health (NIH)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Healthy individuals and subjects that have rheumatoid arthritis may participate in the developmental arm. Healthy individuals may participate in the clearance arm. There will be no randomization.

Women shown to have DCIS or invasive breast cancer by fine needle aspiration cytology and/or core needle biopsy.

Ductal Carcinoma In Situ

Invasive Breast Cancer

Dartmouth-Hitchcock Medical Center

Digital Breast Tomosynthesis Versus Contrast Enhanced Magnetic Resonance Imaging (MRI) for Breast Cancer Staging

A Comparison of the Diagnostic Accuracy of Adjunctive Digital Breast Tomosynthesis Versus Adjunctive Contrast Enhanced Breast Magnetic Resonance Imaging in the Preoperative Assessment of Breast Cancer

Hologic, Inc.

It includes the implant of the Mar-tyn TiN coated stent

Includes all the patients treated with the Vision stent

Coronary Artery Disease

Angioplasty, Transluminal, Percutaneous Coronary

Stents

Mar-Tyn TiN coated Co-Cr Numen stent implant

Vision Co-Cr stent implant

Department of Internal Medicine III (Cardiology), University of Freiburg im Breisgau

Policlinico Universitario di Bari-Emodinamica Interventista

Ospedale San Raffaele- Emodinamica e Cardiologia

Ospedale di Ravenna, U.O. Cardiologia

Campus Biomedico, Cardiologia

CARIM, Department of Cardiology

Cardiocentro Ticino, Cardiologia

European Multicenter, Randomized, Comparative Efficacy/Safety Study of the Mar-Tyn TiN-Coated Stent

A European Multicenter, Randomized, Single Blind Study of the MAR-Tyn Cobalt Chromium TiN-Coated Balloon-Expandable Stent in the Treatment of Patients With de Novo Coronary Artery Lesions

tungsten/vėžys

NIR Fluorescence Imaging of Lymphatic Transport Using ICG

Digital Breast Tomosynthesis Versus Contrast Enhanced Magnetic Resonance Imaging (MRI) for Breast Cancer Staging

European Multicenter, Randomized, Comparative Efficacy/Safety Study of the Mar-Tyn TiN-Coated Stent

Monitoring of Tissue Transfer Flaps by Modulated Imaging (MI) Spectroscopy

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