A Study to Evaluate Organ Level Uptake Repeatability of 124I AT-01 in Subjects With Systemic Amyl… (NCT05235269) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate Organ Level Uptake Repeatability of 124I AT-01 in Subjects With Systemic Amyloidosis
United States33 participantsStarted 2021-11-30
Plain-language summary
This study is designed to assess the repeatability of organ-specific quantitation of radiotracer uptake following Positron Emission Tomography/Computed Tomography (PET/CT) imaging of AT- 01 in subjects with amyloid light chain (AL) or amyloid transthyretin (ATTR) systemic amyloidosis.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Understands the study procedures and is 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.
✓. Male or female ≥18 years of age.
✓. For women of childbearing potential: agreement to remain abstinent 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 124I-AT-01.
✓. A woman is considered of childbearing potential if she is postmenarchal, has not reached a postmenopausal state, and has not undergone surgical sterilization.
✓. 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.
✓. 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.
✓. 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.
✓. For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm, as defined below:
Exclusion criteria
✕. Is pregnant or breast-feeding.
What they're measuring
1
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Timeframe: Day 1 and Week 6
2
Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Timeframe: Day 1 and Week 6
3
Intraclass Correlation Coefficient (ICC) Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake
Timeframe: Day 1 and Week 6
4
Intraclass Correlation Coefficient (ICC) Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake
✕. Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis.
✕. Has received in the last 6 months or are currently receiving treatment with anti-amyloid monoclonal antibody therapy or are expected to begin treatment prior to completing this study.
✕. Has received heparin or heparin analogs within 7 days of Day 1.
✕. Has a significant co-morbidity (e.g., Easter Cooperative Oncology Group (ECOG) score of 3 or greater), New York Heart Association (NYHA) Class IV heart failure, uncontrolled infection, or other ongoing serious illness.
✕. Has active thyroid disease.
✕. Has a known allergy to potassium iodine treatment.
✕. Is receiving hemodialysis or peritoneal dialysis.