Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy

Korábbi kezelés

• 2. Prior liver or heart transplantation.
• 5. History of prior treatment for ATTR cardiomyopathy and/or amyloid neuropathy, or decline clinical tafamidis treatment.

Más betegség

• 3. Active malignancy or non-amyloid disease with an expected survival of less than 1 year
• 7. Known allergic reactions to components of the 18F-flutemetamol and/or polysorbate 80

Egyéb

• 1. Primary amyloidosis (AL) or secondary amyloidosis (AA).
• 4. Inability to lie flat for 60 minutes in the PET scanner
• 6. Pregnancy or lactation
• 8. High risk for non-adherence as determined by screening evaluation.

• 1. Age > 18 years
• 2. Diagnosis of ATTR cardiac amyloidosis (wild-type or V142I ATTR mutation)
  • Diagnosis of ATTR cardiac amyloidosis by established consensus diagnostic criteria of Gillmore et al. (either invasive or non-invasive diagnostic pathways)
• 3. Plan for initiation of tafamidis therapy for clinical indications and agree to continue tafamidis during the duration of the study.
• 4. Stated willingness to comply with all study procedures and availability for the duration of the study
• 5. Able to understand and sign the informed consent document after the nature of the study has been fully explained.
• 6. Women of childbearing potential who are sexually active with a non-sterilized male partner and males who are sexually active with a partner of childbearing potential must agree to use adequate contraception from screening until 30 days after the Flutemetamol.