Molecular Imaging of the Underlying Mechanism of Cardiotoxicity in Patients With Light Chain Amyl… (NCT04105634) | Clinical Trial Compass
TerminatedEarly Phase 1
Molecular Imaging of the Underlying Mechanism of Cardiotoxicity in Patients With Light Chain Amyloidosis Using PET/CT
Stopped: Low accrual
United States3 participantsStarted 2019-10-01
Plain-language 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 be two groups in the study. One group will have PET/CT scans using an imaging drug called 18F-NOS and the other group will have PET/CT scans using a drug called Florbetaben. subject will be assigned to one of the groups when she/he agrees to be in the study.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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 criteria
✕
What they're measuring
1
Measure uptake of [18F]NOS and Florbetaben in patients with AL before and ~4 months (2 +/- weeks) after starting standard therapy using PET/CT
. 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