Status:
TERMINATED
Molecular Imaging of the Underlying Mechanism of Cardiotoxicity in Patients With Light Chain Amyloidosis Using PET/CT
Lead Sponsor:
University of Pennsylvania
Conditions:
Cardiac Amyloidosis
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The research study is being conducted to test how two different types of Positron Emission Tomography (PET/CT) scans could be used to image a type of heart disorder called amyloidosis (AL). There will...
Detailed Description
Immunoglobulin light chain (LC) amyloidosis (AL) is an underdiagnosed monoclonal plasma cell proliferative disorder caused by extracellular deposition of AL fibrils in various tissues and organs, caus...
Eligibility Criteria
Inclusion
- Participants will be at least 18 years of age
- Have an established diagnosis of AL amyloidosis based on standard criteria and planning to start systemic therapy.
- Have cardiac involvement as defined by all of the following:
- Past documented or presently noted clinical signs and symptoms supportive of a diagnosis of heart failure in the setting of a confirmed diagnosis of AL amyloidosis in the absence of an alternative explanation for heart failure
- Either an endomyocardial biopsy demonstrating AL amyloidosis or an echocardiogram demonstrating a mean left ventricular wall thickness at diastole \>12mm in the absence of other causes (e.g. severe hypertension, aortic stenosis), which would adequately explain the degree of wall thickening
- NT-proBNP ≥ 650 pg/mL
- Participants should fall into 1 of the following 2 categories:
- Treatment-naïve or have completed no more than 1 cycle of initial therapy, OR
- Relapsed after 1 or more prior therapies, and at least 6 months from last treatment
- Have serum free light chain (FLC) differential (defined as amyloid-forming FLC minus non-amyloid-forming FLC) ≥ 50 mg/L.
- Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
Exclusion
- Females who are pregnant or breast feeding at the time of the PET/CT scan will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential before the injection of radiotracer.
- Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
- Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
- Less than 6 months life expectancy as deemed by a treating physician
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2024
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04105634
Start Date
October 1 2019
End Date
October 14 2024
Last Update
November 12 2024
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104