Clinical trial NCT05968846: Repeat PET/CT Imaging of Patients With Amyloid 124I-AT-01 to Measure Changes in Organ-specific Amyloid Load
Official title: Repeat PET/CT Imaging of Patients With Systemic Amyloidosis Using Amyloid Reactive Peptide 124I-AT-01 (124I-p5+14, Iodine-124I-evuzamitide) to Measure Changes in Organ-specific Amyloid Load
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Systemic Amyloidosis
Keywords: systemic amyoidosis
p5+14
AT-01
PET/CT
evuzamitide
Lead sponsor: University of Tennessee Graduate School of Medicine
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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 subject's disease status and thereby enable monitoring of disease response over time in terms of organ-specific amyloid load.

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.

Consented eligible patients will provide 3 tablespoons of blood for the following laboratory tests: CMP, CBC, CRP, Troponin, NT-proBNP, LDH, FLC and anti-drug antibody (ADA) analyses. A urine sample will also be collected to assess renal function. If required, a pregnancy test will be administered.

Patients will then undergo a transthoracic echocardiographic examination and vital sign assessment before receiving an intravenous injection of no more than 2 mCi 124I-AT-01 followed, 5 h thereafter, by repeat vital sign measurements and PET/CT imaging from crown to thighs with a dynamic PET acquisition over the heart. Previously acquired 124I- AT-01 PET/CT images will be used as baseline values to determine quantitative changes in uptake of the radiotracer in the heart, liver, spleen, and kidney (and other organs deemed positive following visual inspection of the baseline and repeat imaging) as a measure of changes in amyloid load. Optionally, if the patients can return to the study site within \~30 days post injection of 124I-AT-01, a second (post-injection) blood draw and ADA evaluation will be performed.

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.

Primary outcomes:
measure: To measure visual and quantitative changes in organ-specific uptake of 124I-AT-01
timeFrame: From enrollment to the end of the study is 8 days
Secondary outcomes:
Other outcomes:
measure: Measures of Interest
timeFrame: From enrollment to the end of the study is 8 days
measure: Measure of Interest
timeFrame: From enrollment to the end of the study is 8 days
measure: Measure of Interest
timeFrame: From enrollment to the end of the study is 8 days
measure: Measure of interest
timeFrame: From enrollment to the end of is the study is 8 days
measure: Measure of Interest
timeFrame: From enrollment to the end of the study is 8 days
measure: Measure of Interest
timeFrame: From enrollment to the end of the study is 8 days
Locations:
city: Knoxville
country: United States
facility: University of Tennessee Graduate School of Medicine
state: Tennessee
Study officials:
References: