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.
Single group
99mTc-p5+14 is an amyloid reactive peptide labeled with technetium-99m.
DrugPeptide p5+14 is a pan-amyloid reactive, synthetic 45 L-amino acid polypeptide with a net +12 positive charge that can bind two major components of all extracellular amyloid deposits: (i) hypersulfated heparan sulfate glycosaminoglycans (proteoglycans) and (ii) amyloid fibrils. The polypeptide, labeled with iodine-124, has been shown (study AMY1001) to bind amyloid in all organs including the heart. This study will evaluate a Tc-99m-labeled version of the peptide for gamma imaging.
99mTc-Pyrophosphate
Drug99mTc-PYP is an FDA-approved, commercially available bone-seeking radiotracer used routinely in nuclear medicine. 99mTC-PYP imaging is used clinically for the diagnosis of cardiac ATTR amyloidosis.
Whole body effective dosimetry measurement
Whole body effective radiation dose assessed from analysis of organ-specific radioactivity uptake in planar and SPECT images.
Measure cardiac uptake of 99mTc-p5+14 radioactivity from planar and SPECT/CT images in comparison to 99mTc-PYP uptake
Measurement of 99mTc-p5+14 uptake in the heart of healthy volunteers and patients with systemic AL or ATTR amyloidosis and comparison with contemporaneous 99mTc-PYP cardiac radioactivity.
Measure uptake of 99mTc-p5+14 radioactivity in extracardiac tissues from planar and SPECT/CT images
Measurement of 99mTc-p5+14 radioactivity in abdominothoracic organs of healthy volunteers and patients with systemic AL or ATTR amyloidosis from planar and SPECT/CT images.
Compare planar and SPECT imaging of 99mTc-p5+14 for the detection of cardiac amyloid
To compare the quantitative cardiac uptake of 99mTc-p5+14 and 99mTc-PyP in patients with systemic ATTR amyloidosis imaged by planar gamma scitigraphic and SPECT/CT imaging acquired at 1-hour and 3-hour post-injection.
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University of Tennessee Graduate School of Medicine
Lead sponsor
Bayer
Collaborator
