Status:
COMPLETED
Repeat PET/CT Imaging of Patients With Amyloid 124I-AT-01 to Measure Changes in Organ-specific Amyloid Load
Lead Sponsor:
University of Tennessee Graduate School of Medicine
Conditions:
Systemic Amyloidosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
This is a single center, open label, prospective study using 124I-AT-01 PET/CT imaging to evaluate changes in amyloid load in patients with systemic amyloidosis who had undergone 124I-AT-01 imaging. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2023
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT05968846
Start Date
December 7 2022
End Date
September 1 2023
Last Update
December 5 2024
Active Locations (1)
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1
University of Tennessee Graduate School of Medicine
Knoxville, Tennessee, United States, 37920