Novel Quantitative MRI for Axial Spondyloarthritis
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Neurology, Neurology, Orthopedic |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/27/2019 |
| Start Date: | January 2019 |
| End Date: | June 2021 |
| Contact: | Xiaojuan Li, PhD |
| Email: | lix6@ccf.org |
| Phone: | 510-685-3495 |
This proposal aims to develop novel MR imaging and image processing techniques that will
provide reliable and fully quantitative evaluation of inflammation, chronic structural
changes and vascularity in patients with Ankylosing Spondylitis (AS). The quantitative
evaluation will be more objective and reproducible, more sensitive to subtle changes, and
less time consuming, as compared to the current semi-quantitative evaluation. It will allow
radiologists and rheumatologists to evaluate the inflammation and structural changes more
reliably to improve early diagnosis and treatment response evaluation. The developed
quantification tools can be disseminated to other research and clinical sites for
retrospective and prospective data analysis, and used as outcome measures for future
multi-center trials. The evaluation of vascularity will enhance Investigators understanding
of disease pathophysiology and serve as a novel marker to improve investigators capability of
evaluating and predicting treatment response in AS. The successful implementation will
greatly assist clinicians to optimize individualized therapeutic strategies and ultimately
improve patient care for AS.
provide reliable and fully quantitative evaluation of inflammation, chronic structural
changes and vascularity in patients with Ankylosing Spondylitis (AS). The quantitative
evaluation will be more objective and reproducible, more sensitive to subtle changes, and
less time consuming, as compared to the current semi-quantitative evaluation. It will allow
radiologists and rheumatologists to evaluate the inflammation and structural changes more
reliably to improve early diagnosis and treatment response evaluation. The developed
quantification tools can be disseminated to other research and clinical sites for
retrospective and prospective data analysis, and used as outcome measures for future
multi-center trials. The evaluation of vascularity will enhance Investigators understanding
of disease pathophysiology and serve as a novel marker to improve investigators capability of
evaluating and predicting treatment response in AS. The successful implementation will
greatly assist clinicians to optimize individualized therapeutic strategies and ultimately
improve patient care for AS.
There is a critical and unmet clinical need for non-invasive techniques that provide early
diagnosis as well as reliable and sensitive evaluations of ongoing disease activity and
treatment response in patients with axial spondyloarthritis (axSpA). Imaging plays a key role
to fulfill this goal and there is an increasing trend of applying imaging techniques in the
field of axSpA. However, current imaging techniques, including radiographs and MRI, are
primarily limited to qualitative or semi-quantitative evaluations of disease activity and
structural damage, which is very crude and subjective with considerable inter-reader
variation, and has limited sensitivity of detecting early lesions as well as changes in
inflammatory lesions beyond morphology of bone marrow edema after treatment. Furthermore,
several recent studies reported data of inflammation (bone marrow edema), fatty deposition
and new bone formation after TNF inhibitor (TNFi) treatment in patients with axSpA,
suggesting a complex relationship between inflammation, bone formation, and suppression of
the TNF pathway. These studies also call for differentiating edema for their characteristics
(angiogenesis for example) and inflammation stages (acute and chronic), which will provide
valuable insight on disease pathophysiology as well as on optimizing treatment for individual
patients with axSpA.
The long-term goal is to develop novel quantitative MRI measures that will reliably assess
both inflammation and structural damage, and predict treatment response, remission and
disease progression in axSpA. Compared to current MRI grading systems, such quantitative
measures may be used as more sensitive, specific, reliable and faster imaging markers for
future trials, and eventually for clinical practice to improve patient management in axSpA.
In this proposal, Investigators will focus on patients with clinically diagnosed active
Ankylosing Spondylitis (AS) and will develop novel imaging and image processing techniques
using 3 Tesla MRI. The specific aims are two-folds. Firstly, Investigators will develop
methods that reliably quantify bone marrow edema (BME), fatty deposition (FD) and erosions;
Secondly, Investigators will develop novel quantitative evaluation of perfusion and
vascularity of BME (using dynamic Gd-enhanced MRI), which has not been investigated for axSpA
in the literature.
Investigators will recruit 20 patients with active Ankylosing Spondylitis (AS) using the 1984
modified NY criteria. Fifteen patients will be recruited from the Ankylosing Spondylitis
clinic at UCSF, directed by Dr. Lianne Gensler, and five patients will be recruited from
Rheumatology clinic at the Cleveland Clinic by Dr. Elaine Husni. Drs. Gensler and Husni will
also reach out to the other academic sites and the community private practices to recruit
patients as needed who are starting TNF inhibitor therapy with CZP for their AS. Patients
will be studied at baseline, 4-weeks and 48-weeks after initiation of TNFi treatment.
Advanced quantitative MRI will be applied to evaluate early treatment response at 4-weeks,
and long-term outcomes at 48-weeks. The central hypothesis is that quantitative MRI allows a
fast, specific and reproducible evaluation of disease activity and structural changes in AS,
and provides more superior diagnostic and prognostic capability compared to semi-quantitative
MRI grading systems.
The successful implementation of the proposed study will make significant contributions to
the research and clinical
diagnosis as well as reliable and sensitive evaluations of ongoing disease activity and
treatment response in patients with axial spondyloarthritis (axSpA). Imaging plays a key role
to fulfill this goal and there is an increasing trend of applying imaging techniques in the
field of axSpA. However, current imaging techniques, including radiographs and MRI, are
primarily limited to qualitative or semi-quantitative evaluations of disease activity and
structural damage, which is very crude and subjective with considerable inter-reader
variation, and has limited sensitivity of detecting early lesions as well as changes in
inflammatory lesions beyond morphology of bone marrow edema after treatment. Furthermore,
several recent studies reported data of inflammation (bone marrow edema), fatty deposition
and new bone formation after TNF inhibitor (TNFi) treatment in patients with axSpA,
suggesting a complex relationship between inflammation, bone formation, and suppression of
the TNF pathway. These studies also call for differentiating edema for their characteristics
(angiogenesis for example) and inflammation stages (acute and chronic), which will provide
valuable insight on disease pathophysiology as well as on optimizing treatment for individual
patients with axSpA.
The long-term goal is to develop novel quantitative MRI measures that will reliably assess
both inflammation and structural damage, and predict treatment response, remission and
disease progression in axSpA. Compared to current MRI grading systems, such quantitative
measures may be used as more sensitive, specific, reliable and faster imaging markers for
future trials, and eventually for clinical practice to improve patient management in axSpA.
In this proposal, Investigators will focus on patients with clinically diagnosed active
Ankylosing Spondylitis (AS) and will develop novel imaging and image processing techniques
using 3 Tesla MRI. The specific aims are two-folds. Firstly, Investigators will develop
methods that reliably quantify bone marrow edema (BME), fatty deposition (FD) and erosions;
Secondly, Investigators will develop novel quantitative evaluation of perfusion and
vascularity of BME (using dynamic Gd-enhanced MRI), which has not been investigated for axSpA
in the literature.
Investigators will recruit 20 patients with active Ankylosing Spondylitis (AS) using the 1984
modified NY criteria. Fifteen patients will be recruited from the Ankylosing Spondylitis
clinic at UCSF, directed by Dr. Lianne Gensler, and five patients will be recruited from
Rheumatology clinic at the Cleveland Clinic by Dr. Elaine Husni. Drs. Gensler and Husni will
also reach out to the other academic sites and the community private practices to recruit
patients as needed who are starting TNF inhibitor therapy with CZP for their AS. Patients
will be studied at baseline, 4-weeks and 48-weeks after initiation of TNFi treatment.
Advanced quantitative MRI will be applied to evaluate early treatment response at 4-weeks,
and long-term outcomes at 48-weeks. The central hypothesis is that quantitative MRI allows a
fast, specific and reproducible evaluation of disease activity and structural changes in AS,
and provides more superior diagnostic and prognostic capability compared to semi-quantitative
MRI grading systems.
The successful implementation of the proposed study will make significant contributions to
the research and clinical
Inclusion Criteria:
- Active AS meeting the modified New York criteria
- BASDAI ≥ 4
- Elevated C-Reactive Protein
- ≥ 18 years old
- Initiation of TNFi treatment with CZP
Exclusion Criteria:
- Previous treatment with more than one biologics
- Biologic treatment within six-months (no more than 20% of group (n=4) for patients
with previous biologic treatment)
- Non-response to previous anti TNF treatment
- Fibromyalgia or other reasons for back pain
- Pregnant patients
- Patients on > 10mg of Prednisone per day
We found this trial at
1
site
Click here to add this to my saved trials
