| Eligibility |
Inclusion Criteria:
1. Understands the study procedures and capable of giving signed informed consent, as
described in Appendix 1, which includes compliance with the requirements and
restrictions listed in the informed consent form (ICF) and in this protocol.
2. Male or female =18 years of age.
3. Has a confirmed diagnosis of Amyloid Light-Chain (AL), Transthyretin Amyloidosis
(ATTR), or Leukocyte chemotactic factor 2 amyloidosi (ALECT2), or any other forms of
systemic amyloidosis based on any one of the following:
1. a histologic confirmation with a biopsy containing deposits of apple-green
birefringent, congophilic material;
2. genetic screening with presence of amyloid-related pathology; and/or
3. amyloid-specific imaging study.
4. Has known involvement of at least one thoracoabdominal organ (excluding peripheral
nervous system) by clinical history (e.g., imaging consistent with amyloid deposition,
organ biopsy, elevated amyloid-related biomarkers, etc.).
5. For women of childbearing potential: agreement to remain as abstinent (refrain from
heterosexual intercourse) or use contraceptive methods that result in a failure rate
of <1% per year during the treatment period and for at least 90 days after the last
dose of study intervention.
1. A woman is considered of childbearing potential if she is postmenarchal, has not
reached a postmenopausal state (= 12 months of amenorrhea with no identified
cause other than menopause), and has not undergone surgical sterilization
(removal of ovaries and/or uterus). The definition of childbearing potential may
be adapted for alignment with local guidelines or requirements.
2. Examples of contraceptive methods with a failure rate of < 1% per year include
bilateral tubal ligation, male sterilization, established, proper use of hormonal
contraceptives that inhibit ovulation, hormone-releasing intrauterine devices and
copper intrauterine devices.
3. Contraception methods that do not result in a failure rate of <1% per year such
as cap, diaphragm, or sponge with spermicide, or male or female condom with or
without spermicide, are not acceptable.
4. The reliability of sexual abstinence should be evaluated in relation to the
duration of the clinical trial and the preferred and usual lifestyle of the
subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or
postovulation methods) and withdrawal are not acceptable methods of
contraception.
6. For men: agreement to remain abstinent or use contraceptive measures and agreement to
refrain from donating sperm, as defined below:
1. With female partners of childbearing potential, men must remain abstinent or use
a condom plus an additional contraceptive method that together result in a
failure rate of < 1% per year during the treatment period and for at least 30
days plus 90 days (a spermatogenesis cycle) after the last dose of study
intervention. Men must refrain from donating sperm during this same time period.
Exclusion Criteria:
1. Is pregnant or breast-feeding.
2. Is mentally or legally incapacitated, has significant emotional problems at the time
of the study, or has a history of psychosis.
3. Has participated in another nuclear medicine amyloid imaging clinical trial protocol
and received tracer injection in the 4 months prior to Screening.
4. Has a significant co-morbidity (e.g., ECOG score of 3 or greater), NYHA Class IV heart
failure, uncontrolled infection, or other ongoing serious illness.
5. Has a known allergy to iOSAT iodine treatment.
6. Has end-stage renal disease and is receiving hemodialysis or peritoneal dialysis.
7. Has received an investigational agent within five half-lives of the agent or 30 days,
whichever is longer, prior to Screening.
8. Has any illness that, in the opinion of the Investigator, might confound the results
of the study or pose additional risk to the subject.
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