NCT05968846 · REGISTRY CONDITION SEARCH

Repeat PET/CT Imaging of Patients With Amyloid 124I-AT-01 to Measure Changes in Organ-specific Amyloid Load

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2026-09-02

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.

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What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

To Measure Visual Changes and Quantitative Changes in Organ-specific Uptake of 124I-AT-01

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outcome · POSTED

Measures of Interest

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outcome · POSTED

Measure of Interest

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outcome · POSTED

Measure of Interest

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outcome · POSTED

Measure of Interest

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outcome · POSTED

Measure of Interest

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
124I-AT-01 (124I-p5+14, iodine-124I evuzamitide) is an iodine-124 (124I) labeled 45 L-amino acid peptide suitable for PET/CT imaging. The peptide binds many forms of amyloid through multivalent electrostatic interactions with the amyloid fibril and ubiquitous heparan sulfate proteoglycans. 124I-AT-01 has been evaluated previously in an open-label Phase 1/2 clinical trial, AMY1001, performed at the University of Tennessee Medical Center (IND# 132282; NCT T03678259). In this repeat imaging study, patients previously enrolled in the AMY1001 study, in whom positive PET/CT imaging findings were observed will undergo repeat imaging to assess changes in radiotracer uptake in the liver, spleen, heart and kidneys.
intervention Names
Drug: Injection of peptide p5+14 radiolabeled with iodine-124 (124I-AT-01)
label
Patients will receive a single IV injection of 124I-AT-01 radiotracer and PET/CT imaging
type
EXPERIMENTAL

interventions

arm Group Labels
Patients will receive a single IV injection of 124I-AT-01 radiotracer and PET/CT imaging
description
124I-AT-01 (124I-p5+14, iodine-124I evuzamitide) is a a novel iodine-124 (124I) labeled 45 L-amino acid peptide suitable for PET/CT imaging that has been shown to bind systemic amyloid deposits of diverse types in all organs, including the heart. The peptide binds amyloid through multivalent electrostatic interactions with the amyloid fibril and ubiquitous heparan sulfate proteoglycans.
name
Injection of peptide p5+14 radiolabeled with iodine-124 (124I-AT-01)
other Names
124I-p5+14
iodine-124-evuzamitide
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

BASIC_SCIENCE

Enrollment

count: 19
type: ACTUAL

Registered outcome plans (not posted results)

other Outcomes

description
For AL, ATTR and all patients, we will correlate visual and quantitative changes in 124I- AT-01 uptake, from baseline, in the heart, liver and kidney with echocardiographic parameters (including left ventricular wall thickness (cm), intraventricular wall thickness (cm), and global logitudinal strain (%)) and serum biomarker levels (including NTproBNP, eGFR, creatinine, AST and ALT) assessed prior to imaging and from data recorded in the patients' medical record.
measure
Measures of Interest
time Frame
Baseline (assessed during previous study NCT03678259) and Repeat Assessment (Day 1 to Day 2 of current study)
description
For AL, ATTR and all patients, we will correlate visual and quantitative changes in organ-specific 124I-AT-01 uptake (percent change in radiotracer uptake from baseline) with change in disease status (progression, response, or stable state) when this can be established from data (serum biomarkers and cardiac imaging parameters) in the patients' medical record or collected during the AMY1001 trial. Disease status is categorized based on NTproBNP, creatinine, blood urea nitrogen or alkaline phosphatase compared to baseline values taken at the original scan time or noted in the medical record based on a sum of clinical findings. Progression is defined as a ≥30% increase; Response is defined as a ≥30% decrease; and Stable disease is defined as a \<30% increase or decrease.
measure
Measure of Interest
time Frame
From enrollment to the end of the study is 8 days
description
For AL patients, correlate visual and quantitative changes in organ-specific 124I-AT-01 uptake (percent change in radiotracer uptake from baseline) with change in serum free light chains over the period between imaging studies, when available in the medical record. Baseline assessments reflect the values assessed during the previous study (NCT03678259). Repeat assessments reflect the values assessed during this current study. The 'change in' values are calculated as the repeat value from this current study minus the baseline value from the previous study (NCT03678259).
measure
Measure of Interest
time Frame
Baseline (assessed during previous study NCT03678259) and Repeat Assessment (Day 1 to Day 2 of current study)
description
Compare changes, when possible, in radiotracer distribution from baseline based on analysis dynamic PET data.
measure
Measure of Interest
time Frame
From enrollment to the end of the study is 8 days
description
Compare changes, when possible, in ejection fraction from baseline based on analysis dynamic PET data.
measure
Measure of Interest
time Frame
From enrollment to the end of the study is 8 days

primary Outcomes

description
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. The specific aim of this study is to measure visual and quantitative changes in organ-specific uptake of 124I-AT-01 from baseline, in patients with systemic amyloidosis, using PET/CT imaging
measure
To Measure Visual Changes and Quantitative Changes in Organ-specific Uptake of 124I-AT-01
time Frame
Baseline PET/CT imaging from AMY1001 (NCT03678259) and repeat PET/CT imaging on Day 2 of the current study

Full study description

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: complete blood count (CMP), complete blood count (CBC), C-reactive protein (CRP), Troponin, N-terminal fragment of prohormone brain natriuretic peptide (NT-proBNP), lactate dehydrogenase (LDH), Free Light Chain (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.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Independent clinical review pending · Not medical advice