ATTREPIC-TTRNCT07591038
PET/CT Imaging in Carriers of TTR Mutations
An observational study of ATTR and ATTR Gene Mutation, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if TTR gene carriers have early signs of a type of heart disease called amyloidosis using a new radiotracer dye (iodine-124 evuzamitide, I-124E). Participants will undergo a screening that includes a medical history review and completion of quality-of-life surveys. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- ATTR, ATTR Gene Mutation, Cardiomyopathy
- What is being tested?
- Iodine-124 Evuzamitide (I-124E)
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2026to 30 Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will enroll 50 carriers of pathogenic TTR alleles without HF, 20 patients with ATTR-CA, and 10-race matched non-carrier controls to have PET/CT I-124E imaging.
Who may be able to join
- men and women ages 30-80 who are pathogenic allele TTR carriers without history of HF (this will be assessed by study personnel and defined as : 1) No history of hospitalization within the previous 12 months for management of HF; 2) Without an elevated B-type natriuretic peptide level ≥100 pg/mL or NT-proBNP ≥360 pg/mL within the previous 12 months; or 3) a clinical diagnosis of HF from a treating clinician)
- have already completed the protocol for NCT05489549 at UT Southwestern only
- men and women ages 30-80 who have symptomatic V122I hATTR-CA as determined by a history of HF (this will be assessed by study personnel and defined as : 1) history of hospitalization within the previous 12 months for management of HF; 2) an elevated B-type natriuretic peptide level ≥100 pg/mL or NT-proBNP ≥360 pg/mL within the previous 12 months; or 3) a clinical diagnosis of HF from a treating clinician)
- hATTR-CA previously diagnosed histologically by amyloid staining and tissue typing with immunohistochemistry or mass spectrometry or by bone scintigraphy in without abnormal M-protein
- TTR gene sequencing confirming the TTR variant
- have already completed the protocol for NCT05489549 at UT Southwestern only
- men and women ages 30-80 who are non-carriers without history of HF (this will be assessed by study personnel and defined as: 1) No history of hospitalization within the previous 12 months for management of HF; 2) Without an elevated B-type natriuretic peptide level ≥100 pg/mL or NT-proBNP ≥360 pg/mL within the previous 12 months; or 3) No clinical diagnosis of HF from a treating clinician
- have previously enrolled in the Dallas Heart Study
Who cannot join
- a self-reported history or clinical history of HF
- other known causes of cardiomyopathy
- history of light-chain cardiac amyloidosis
- prior type 1 myocardial infarction
- cardiac transplantation
- liver transplantation
Show all 43Show fewer
- body weight or habitus that exceeds the site-specific PET/CT parameters
- estimated glomerular filtration rate ≤30 mL/min/1.73 m2
- inability to safely undergo PET/CT
- participating in a clinical trial for ATTR treatments or taking a fibril deleting agent
- pregnancy or breastfeeding
- patients taking heparin or heparin derivatives for anticoagulation
- allergy to potassium iodide
- known uncorrected thyroid disorder
- Subjects with symptomatic hATTR-CA (may be supplemented with other ATTR-CA genotypes including wild-type in the occasion of slow enrollment):
- other known causes of cardiomyopathy
- history of light-chain cardiac amyloidosis
- cardiac transplantation
- liver transplantation
- history of type I myocardial infarction
- body weight or habitus that exceeds the site-specific PET/CT parameters
- estimated glomerular filtration rate ≤30 mL/min/1.73 m2
- inability to safely undergo PET/CT
- participating in a clinical trial for ATTR treatments or taking a fibril deleting agent
- patients taking heparin or heparin derivatives for anticoagulation
- pregnancy or breastfeeding
- allergy to potassium iodide
- known uncorrected thyroid disorder
- Non-carrier race-matched controls:
- a self-reported history or clinical history of HF
- other known causes of cardiomyopathy
- history of light-chain cardiac amyloidosis
- prior type 1 myocardial infarction
- cardiac transplantation
- liver transplantation
- body weight or habitus that exceeds the site-specific PET/CT parameters
- estimated glomerular filtration rate ≤30 mL/min/1.73 m2
- inability to safely undergo PET/CT
- participating in a clinical trial for ATTR treatments or taking a fibril deleting agent
- patients taking heparin or heparin derivatives for anticoagulation
- pregnancy or breastfeeding
- allergy to potassium iodide
- known uncorrected thyroid disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UT Southwestern Medical Center
Dallas, Texas, 75248
Jerah Sanchez, 214-645-7303, jerahmarie.sanchez@utsouthwestern.edu
Justin L Grodin, MD MPH
About this study
Official title: Iodine-124 Evuzamitide PET/CT Imaging in Carriers of TTR Mutations
The purpose of this study is to determine if TTR gene carriers have early signs of a type of heart disease called amyloidosis using a new radiotracer dye (iodine-124 evuzamitide, I-124E).
Participants will undergo a screening that includes a medical history review and completion of quality-of-life surveys. Once screening is complete, participants will undergo an imaging test called a positron emission tomography (PET) scan combined with computed tomography (PET/CT) to make images of the body. The new radiotracer dye (I-124E, a radioactive contrast) will be used during the PET/CT to make amyloidosis visible in the heart and body.
Read the detailed description
This will be a cross-sectional cohort study of 50 carriers of pathogenic TTR alleles without HF; 10-race matched non-carrier controls; and 20 patients with ATTR-CA. Participants will undergo standardized, PET/CT direct amyloid imaging assessments with I-124E to test the hypothesis that carriers of pathogenic TTR alleles without HF will have LV%ID intermediate to non-carrier controls and patients with ATTR-CA. This will address the fundamental questions of whether and to what extent cardiac amyloid infiltration is present in carriers of pathogenic TTR alleles prior to ATTR-CA disease onset.
- Being tested
- Iodine-124 Evuzamitide (I-124E)
- Keywords
- transthyretin, amyloidosis, carriers of abnormal gene, TTR, PET/CT, evuzamitide, ATTR, TTR gene
- Medical subject headings
- Cardiomyopathies, Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodine-124 Evuzamitide (I-124E)Diagnostic test
I-124E is a novel amyloidophilic peptide radiotracer that binds via electrostatic interactions to electronegative glycosaminoglycans and amyloid protein fibrils - both are ubiquitous among amyloid deposits. PET/CT I-124E has acceptable dosimetry estimates and is acceptable for whole-body PET/CT imaging. Data from patients with amyloidosis has established that tracer uptake is present in locations of clinically anticipated amyloid deposits and in locations not clinically appreciated, but also consistent with the distribution of amyloid in the human body (e.g. heart, kidney, spleen).
| Study group | Role | What they receive |
|---|---|---|
| Pathogenic TTR Allele Carriers without Heart Failure | Not described Receives: Diagnostic Test: Iodine-124 Evuzamitide (I-124E) | |
| Subjects with Symptomatic ATTR-CA | Not described Receives: Diagnostic Test: Iodine-124 Evuzamitide (I-124E) | |
| Non-carrier race-matched controls | Not described Receives: Diagnostic Test: Iodine-124 Evuzamitide (I-124E) |
What is being measured
The primary outcome is the main question the study is designed to answer.
LV % Injected dose
Evidence of subclinical cardiac amyloid infiltration as measured by PET/CT quantification imaging with I-124E. This will be defined as LV % injected dose (LV%ID = volume of interest [VOI] mean activity concentration in the LV X VOI volume / injected activity). LV%ID is an ideal metric to assess cardiac amyloid burden because it is: 1) correlated with validated metrics assessing cardiac amyloid burden; 2) sensitive for detection of early disease (patchy vs. diffuse uptake); and 3) highly repeatable and standardizable to other metrics of radiotracer uptake. LV%ID is adjusted for injected activity, but not for body weight, because the latter is unnecessary for a radiotracer accumulating in the heart and specific organs, not in the whole body.
Measured: PET/CT Scan Visit
Secondary outcomes (16)
LVFW SUVR, mean
Measured: PET/CT Scan Visit
LVFW wall SUVR, max
Measured: PET/CT Scan Visit
IVS SUVR, mean
Measured: PET/CT Scan Visit
IVS SUVR, max
Measured: PET/CT Scan Visit
RVFW SUVR, mean
Measured: PET/CT Scan Visit
RVFW SUVR, max
Measured: PET/CT Scan Visit
RV % Injected Dose (RV%ID)
Measured: PET/CT Scan Visit
LV Cardiac Amyloid Activity (CAA)
Measured: PET/CT Scan Visit
LV Target-to-Background Ratio (TBR)
Measured: PET/CT Scan Visit
RV Cardiac Amyloid Activity (CAA)
Measured: PET/CT Scan Visit
RV Target-to-Background Ratio (TBR)
Measured: PET/CT Scan Visit
Left Atrial Uptake
Measured: PET/CT Scan Visit
Right Atrial Uptake
Measured: PET/CT Scan Visit
Liver Uptake
Measured: PET/CT Scan Visit
Spleen Uptake
Measured: PET/CT Scan Visit
Kidney Uptake
Measured: PET/CT Scan Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start14 Nov 2026 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ATTRStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Bayer
- Responsible party
- Principal investigator, Justin Grodin, University of Texas Southwestern Medical Center
- Investigators
- Justin L Grodin, MD MPH, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591038
- Sponsor's protocol ID
- STU-2026-0286
- Other IDs
- R01HL172993
- Acronym
- EPIC-TTR
- Status last verified
- Oct 2026
- First submitted
- 8 May 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iodine-124 Evuzamitide PET/CT Imaging in Carriers of TTR Mutations
- ClinicalTrials.gov ID
- NCT07591038
- Acronym / sponsor ID
- EPIC-TTR / STU-2026-0286
- Keywords
- transthyretin, amyloidosis, carriers of abnormal gene, TTR, PET/CT, evuzamitide, ATTR, TTR gene
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Bayer
- Study start
- 14 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if TTR gene carriers have early signs of a type of heart disease called amyloidosis using a new radiotracer dye (iodine-124 evuzamitide, I-124E).
Participants will undergo a screening that includes a medical history review and completion of quality-of-life surveys. Once screening is complete, participants will undergo an imaging test called a positron emission tomography (PET) scan combined with computed tomography (PET/CT) to make images of the body. The new radiotracer dye (I-124E, a radioactive contrast) will be used during the PET/CT to make amyloidosis visible in the heart and body.
Detailed description
This will be a cross-sectional cohort study of 50 carriers of pathogenic TTR alleles without HF; 10-race matched non-carrier controls; and 20 patients with ATTR-CA. Participants will undergo standardized, PET/CT direct amyloid imaging assessments with I-124E to test the hypothesis that carriers of pathogenic TTR alleles without HF will have LV%ID intermediate to non-carrier controls and patients with ATTR-CA. This will address the fundamental questions of whether and to what extent cardiac amyloid infiltration is present in carriers of pathogenic TTR alleles prior to ATTR-CA disease onset.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pathogenic TTR Allele Carriers without Heart Failure | – | Diagnostic Test: Iodine-124 Evuzamitide (I-124E) |
| Subjects with Symptomatic ATTR-CA | – | Diagnostic Test: Iodine-124 Evuzamitide (I-124E) |
| Non-carrier race-matched controls | – | Diagnostic Test: Iodine-124 Evuzamitide (I-124E) |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will enroll 50 carriers of pathogenic TTR alleles without HF, 20 patients with ATTR-CA, and 10-race matched non-carrier controls to have PET/CT I-124E imaging.
Key inclusion criteria (8 listed)
- men and women ages 30-80 who are pathogenic allele TTR carriers without history of HF (this will be assessed by study personnel and defined as : 1) No history of hospitalization within the previous 12 months for management of HF; 2) Without an elevated B-type natriuretic peptide level ≥100 pg/mL or NT-proBNP ≥360 pg/mL within the previous 12 months; or 3) a clinical diagnosis of HF from a treating clinician)
- have already completed the protocol for NCT05489549 at UT Southwestern only
- men and women ages 30-80 who have symptomatic V122I hATTR-CA as determined by a history of HF (this will be assessed by study personnel and defined as : 1) history of hospitalization within the previous 12 months for management of HF; 2) an elevated B-type natriuretic peptide level ≥100 pg/mL or NT-proBNP ≥360 pg/mL within the previous 12 months; or 3) a clinical diagnosis of HF from a treating clinician)
- hATTR-CA previously diagnosed histologically by amyloid staining and tissue typing with immunohistochemistry or mass spectrometry or by bone scintigraphy in without abnormal M-protein
- TTR gene sequencing confirming the TTR variant
Key exclusion criteria (43 listed)
- a self-reported history or clinical history of HF
- other known causes of cardiomyopathy
- history of light-chain cardiac amyloidosis
- prior type 1 myocardial infarction
- cardiac transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iodine-124 Evuzamitide (I-124E)I-124E is a novel amyloidophilic peptide radiotracer that binds via electrostatic interactions to electronegative glycosaminoglycans and amyloid protein fibrils - both are ubiquitous among amyloid deposits. PET/CT I-124E has acceptable dosimetry estimates and is acceptable for whole-body PET/CT imaging. Data from patients with amyloidosis has established that tracer uptake is present in locations of clinically anticipated amyloid deposits and in locations not clinically appreciated, but also consistent with the distribution of amyloid in the human body (e.g. heart, kidney, spleen). | Diagnostic test | Non-carrier race-matched controls, Pathogenic TTR Allele Carriers without Heart Failure, Subjects with Symptomatic ATTR-CA |
Primary outcome
LV % Injected dose
Time frame: PET/CT Scan Visit
Evidence of subclinical cardiac amyloid infiltration as measured by PET/CT quantification imaging with I-124E. This will be defined as LV % injected dose (LV%ID = volume of interest [VOI] mean activity concentration in the LV X VOI volume / injected activity). LV%ID is an ideal metric to assess cardiac amyloid burden because it is: 1) correlated with validated metrics assessing cardiac amyloid burden; 2) sensitive for detection of early disease (patchy vs. diffuse uptake); and 3) highly repeatable and standardizable to other metrics of radiotracer uptake. LV%ID is adjusted for injected activity, but not for body weight, because the latter is unnecessary for a radiotracer accumulating in the heart and specific organs, not in the whole body.
16 secondary outcomes
LVFW SUVR, mean
Time frame: PET/CT Scan Visit
LVFW wall SUVR, max
Time frame: PET/CT Scan Visit
IVS SUVR, mean
Time frame: PET/CT Scan Visit
IVS SUVR, max
Time frame: PET/CT Scan Visit
RVFW SUVR, mean
Time frame: PET/CT Scan Visit
RVFW SUVR, max
Time frame: PET/CT Scan Visit
RV % Injected Dose (RV%ID)
Time frame: PET/CT Scan Visit
LV Cardiac Amyloid Activity (CAA)
Time frame: PET/CT Scan Visit
LV Target-to-Background Ratio (TBR)
Time frame: PET/CT Scan Visit
RV Cardiac Amyloid Activity (CAA)
Time frame: PET/CT Scan Visit
RV Target-to-Background Ratio (TBR)
Time frame: PET/CT Scan Visit
Left Atrial Uptake
Time frame: PET/CT Scan Visit
Right Atrial Uptake
Time frame: PET/CT Scan Visit
Liver Uptake
Time frame: PET/CT Scan Visit
Spleen Uptake
Time frame: PET/CT Scan Visit
Kidney Uptake
Time frame: PET/CT Scan Visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Justin L Grodin, MD MPH principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ATTR and ATTR Gene Mutation, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jerah Sanchez (214-645-7303, jerahmarie.sanchez@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LV % Injected dose (time frame: PET/CT Scan Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.