This study will investigate 99mTc-p5+14, an amyloid-reactive synthetic peptide, p5+14, radiolabeled with technetium-99m, as a radiotracer for detecting paamyloid deposits in patients with AL or ATTR-associated systemic amyloidosis, notably with cardiac involvement.
Understand the study procedures and agree to participate in the study by giving written informed consent.
Be male or female >18 years of age.
WOCBP (those who have not been surgically sterilized, are not postmenopausal [i.e., last menstrual period >2 years ago without pharmaceutical intervention], and women who are fertile) must have a negative pregnancy test prior within 24 h prior to infusion.
WOCBP who are not exclusively in same-sex relationships and male participants with female sexual partners who are WOCBP must agree to use adequate contraceptive methods, defined as use of a condom by the male partner combined with use of a highly effective method of contraception by the female partner, for at least 2.5 days after injection of 99mTc-p5+14.
Due to annual dosimetry limitations, patients who have participated in another nuclear medicine amyloid imaging clinical trial protocol and received tracer injection in the last 6 months.
Is pregnant or breast-feeding.
Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis.
Receiving hemodialysis or peritoneal dialysis.
University of Tennessee Graduate School of Medicine
Lead sponsor
Bayer
Collaborator