University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT05162638
In this study, lymph fluid will be collected by cannulation of the thoracic duct, a minimally invasive procedure performed by interventional radiologists. Single time point and serial collection through an indwelling cannula will allow for comparisons between immune cells in the periphery and deep lymphatic system in MS and healthy controls and in MS, changes in responses to a FDA approved therapy ofatumumab.
Interested in participating?
Request Info18 year–40 year
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For participants with MS following additional criteria need to be met:
Exclusion criteria
Contrast is injected into lymph nodes until lymphatics visualized at about level of L3 lumbar spine. After target lymphatic vessel is identified, needle is passed transabdominally into the vessel. Guidewire is advanced through the needle into the lymph vessel & advanced into thoracic duct. Microcatheter is then advanced into thoracic duct over the wire.
IN & OUT-up to 100mL collected via catheter over 30-min at 2 levels within thoracic duct, then catheter removed.
INDWELLING-As described above, then guidewire placed through original catheter & advanced into subclavian vein. Vascular sheath is placed into vein in the upper arm under ultrasound/fluoroscopy guidance. Wire in the subclavian vein then snared through venous access sheath & pulled out. Catheter then threaded & advanced over the wire until tip is in thoracic duct. Catheter from thoracic duct removed, leaving catheter extending from arm into thoracic duct. Catheter left in place up to 21 days for sampling.
Time frame: up to 21 days
Quantified as percent of the study population experiencing serious adverse event from in-and-out catherization procedure and from "indwelling" catheterization procedure
Time frame: up to 21 days
Change in proportion of flow cytometry defined naïve (CD27-) and memory (CD27+) B cells in thoracic duct of patients with MS prior to and following anti-CD20 therapy with Ofatumumab
Time frame: up to 21 days
Comparison of immune cell profiles determined by flow cytometry of lymphatic fluid and blood between MS and healthy controls
Time frame: up to 21 days
Comparison of immune cell profiles determined by flow cytometry of lymphatic fluid and blood of MS patients prior to and following treatment with the anti-CD20 Ofatumumab
University of Pennsylvania
Other
Analysis of Lymphatic Fluid From the Thoracic Duct of Healthy People and People With Multiple Sclerosis (MS) Before and After Ofatumumab Treatment
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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