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Completed
NCT05968846
Repeat PET/CT Imaging of Patients With Amyloid 124I-AT-01 to Measure Changes in Organ-specific Amyloid Load
Conditions: Systemic Amyloidosis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 19
Sponsor: University of Tennessee Graduate School of Medicine
Location: University of Tennessee Graduate School of Medicine Knoxville Tennessee
Summary
The goal of this research study is to determine whether changes in organ-specific uptake of 124I- AT-01 can be measured by PET/CT imaging and further, whether these values correlate with changes in a subject's disease status and thereby enable monitoring of disease response over time in terms of organ-specific amyloid load.
Eligibility Criteria
Inclusion Criteria:
* Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements.
* Must have a diagnosis of systemic amyloidosis based on the patient's medical record.
* Must have undergone PET/CT imaging with 124I-AT-01 as part of the AMY1001 study (IND #132282) with visually positive uptake of radiotracer in at least one abdominothoracic organ.
* Must have been imaged with 124I-AT-01 as part of the AMY1001 study (IND #132282) more than 12 months prior to repeat imaging.
* Females: must be non-pregnant and non-lactating and either: surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy); post-menopausal (defined as 12 months of spontaneous amenorrhea in females \> 55 years of age or, in females ≤ 55 years, 12 months of spontaneous amenorrhea without an alternative medical cause and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the laboratory involved).
Exclusion Criteria:
* Disabling dementia or other mental or behavioral disease.
* Patients on dialysis.
* Inability or unwillingness to comply with the study requirements.
* Patients taking heparin, or heparin derivatives (e.g. low molecular weight heparins) for anticoagulation.
* Other reason that would make the subject inappropriate for entry into this study.
* Inability to lie still for 60 minutes on the PET/CT scanner.
* History of iodine (potassium iodide) allergy.
* Positive ADA finding defined as significantly higher than normal human serum mean values AND with a mean value at least five times greater than the mean value of the normal human serum control.
Source: ClinicalTrials.gov (NCT05968846). StuddyBuddy aggregates publicly available trial information.