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The purpose of this study is to test MRI methods for evaluating patients with
Scleroderma-associated interstitial lung disease.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
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
Arm 1 (UTE MRI in patients with Scleroderma)
Inclusion Criteria:
- Age ≥ 18 years of age.
- Subject has clinical diagnosis of scleroderma.
- Chest CT scan within 1 month prior to screening or Chest CT scan will be completed
within 1 month post study enrollment.
- Ability to adhere to the study visit schedule, adhere, and comply with all protocol
requirements.
- Ability to understand and provide written informed consent.
Exclusion Criteria:
- Subject unable to undergo MRI based on MRI safety screening.
- Pregnant or breastfeeding female subjects.
- Prisoners or incarcerated individuals.
- Any in-patient hospitalization (defined as greater than 23 hours) within 30 days of
study enrollment.
- Any major surgical procedure within 90 days prior to study enrollment or planned
surgical procedure during the study period.
- Concomitant medical disorder, condition, or history, that in the opinion of the
Investigator would impair the subject's ability to participate in or complete the
requirements of the study.
- Other medical or psychiatric condition which, in the opinion of the Investigator,
would place the subject at increased risk or would preclude obtaining voluntary
consent or would confound the objectives of the study.
Arm 2 (Hyperpolarized 129Xe MRI in Patients with Scleroderma ILD)
Inclusion Criteria:
- Age ≥ 18 years of age.
- Subject clinically diagnosed with SSc-ILD.
- Subject initiating background SSc-ILD therapy within ±30 days of visit 1.
(i.e.
patient cannot have begun therapy for SSc-ILD more than 30 days prior to visit 1, or
must be clinically scheduled to initiate therapy within 30 days after visit 1).
- FVC % Predicted ≥45% pre-bronchodilator within 30 days prior to screening or at
baseline.
- DLCO % Predicted ≥30% within 30 days prior to screening or at baseline.
- Oxygen saturation >87% on room air or with supplemental oxygen.
- Ability to adhere to the study visit schedule, adhere, and comply with all protocol
requirements.
- Ability to understand and provide written informed consent.
Exclusion Criteria:
- Subject unable to undergo MRI based on MRI safety screening.
- Diagnosis of IPF based on ATS/ERS/JRS/ALAT 2018 Guidelines.
- Significant Pulmonary Arterial Hypertension (PAH) defined by any of the following:
1.
Previous clinical or echocardiographic evidence of significant right heart
failure. 2. History of right heart catheterization showing a cardiac index ≤ 2 l/min/m²
3. PAH requiring parenteral therapy with epoprostenol/treprostinil.
- Any in-patient hospitalization (defined as greater than 23 hours) within 30 days of
study enrollment.
- Any major surgical procedure within 90 days prior to study enrollment or planned
surgical procedure during the study period.
- Concomitant medical disorder, condition, or history, that in the opinion of the
Investigator would impair the subject's ability to participate in or complete the
requirements of the study.
- Other medical or psychiatric condition which, in the opinion of the Investigator,
would place the subject at increased risk or would preclude obtaining voluntary
consent or would confound the objectives of the study.
- Subject has been on therapy for SSc-ILD for >30 days prior to baseline MRI.
- Pregnancy (Visit 1 or Visit 2) or intention to become pregnant (Visit 2 only)
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.
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 Kansas Medical Center
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
N/A
Principal Investigator Affiliation
N/A
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Other
Overall Status
Recruiting
Countries
United States
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Scleroderma
Additional Details
1. Quantify the sensitivity and specificity of UTE MRI in screening for
scleroderma-associated interstitial lung disease. ILD is relatively common in SSc, but
current clinical standards require screening using HRCT. UTE MRI can provide images of
pulmonary structure with contrast and resolution approaching that of CT. We hypothesize
that UTE MRI will have high sensitivity and specificity (>80%) to the presence of ILD as
determined by HRCT.
Aim. 2. Quantify treatment response in patients with SSc-ILD using hyperpolarized 129Xe MRI. The
optimal treatment for SSc-ILD is not known, and it is challenging to assess the efficacy
of therapy. Hyperpolarized 129Xe MRI is highly sensitive to the pathophysiology
associated with ILD, which suggests that it may be more sensitive to treatment response
than conventional methods. We hypothesize that hyperpolarized 129Xe MRI biomarkers will
be sensitive to lung function improvement or decline earlier than standard clinical
measures (6MWD, FVC, DLCO, Dyspnea score).
Arms & Interventions
Arms
: Scleroderma
Patients with Scleroderma will be imaged with UTE MRI to compare MRI with CT for identifying Interstitial Lung Disease
: Scleroderma ILD
Patients with Scleroderma ILD who are initiating treatment will be imaged using hyperpolarized 129Xe MRI to assess treatment efficacy.
Interventions
Diagnostic Test: - MRI
Patients will be imaged using MRI
Drug: - Hyperpolarized Xe129
Hyperpolarized Xe129 will be used to image the lungs of a subset of participants.
Diagnostic Test: - HRCT
High Resolution Computer Tomography
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.
University of Kansas Medical Center, Kansas City, Kansas
