Cardiomyopathies, PrimaryPhase 1NCT05374564

Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy

A Phase 1 study testing (18F)Flutemetamol in people with Cardiomyopathies, Primary, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

18F-Flutemetamol (Vizamyl) is a radioactive diagnostic agent indicated and FDA-approved for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) or other causes of cognitive… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiomyopathies, Primary
What is being tested?: (18F)Flutemetamol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 16 Aug 2022to 14 Nov 2024
Phase: Phase 1
Are there results?: None posted in the registry

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Age > 18 years
2. Diagnosis of ATTR cardiac amyloidosis (wild-type or V142I ATTR mutation)
Diagnosis of ATTR cardiac amyloidosis by established consensus diagnostic criteria of Gillmore et al. (either invasive or non-invasive diagnostic pathways)
3. Plan for initiation of tafamidis therapy for clinical indications and agree to continue tafamidis during the duration of the study.
4. Stated willingness to comply with all study procedures and availability for the duration of the study
5. Able to understand and sign the informed consent document after the nature of the study has been fully explained.
6. Women of childbearing potential who are sexually active with a non-sterilized male partner and males who are sexually active with a partner of childbearing potential must agree to use adequate contraception from screening until 30 days after the Flutemetamol.

Who cannot join

1. Primary amyloidosis (AL) or secondary amyloidosis (AA).
2. Prior liver or heart transplantation.
3. Active malignancy or non-amyloid disease with an expected survival of less than 1 year
4. Inability to lie flat for 60 minutes in the PET scanner
5. History of prior treatment for ATTR cardiomyopathy and/or amyloid neuropathy, or decline clinical tafamidis treatment.
6. Pregnancy or lactation
7. Known allergic reactions to components of the 18F-flutemetamol and/or polysorbate 80
8. High risk for non-adherence as determined by screening evaluation.

Trial locations and contacts

1 site in 1 country.

United States1 site

Yale University
New Haven, Connecticut, 06520

Other trials in United States

About this study

Read the detailed description

The goal of this project is to perform a proof-of-concept study to compare the ability of quantitative parametric cardiac 18F-flutemetamol positron emission tomography (PET) to assess baseline and change in disease burden after six months of therapy with tafamidis treatment in 12 patients diagnosed with transthyretin cardiac amyloidosis (ATTR-CA) at Yale-New Haven Hospital. The primary outcome of the study will be comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET metrics between the baseline and six-month 18F-flutemetamol PET scans versus clinical stage and echocardiographic features (wall thickness, strain, LVEF).

Conditions: Cardiomyopathies, Primary
Being tested: (18F)Flutemetamol
Keywords: Transthyretin amyloidosis
Medical subject headings: Cardiomyopathies, Amyloidosis, Hereditary, Transthyretin-Related

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

(18F)FlutemetamolDrug
Also called Vizamyl
18F-Flutemetamol binds to β-amyloid plaques and the F-18 isotope produces a positron signal that is detected by a PET scanner. Multiple recent studies have shown that thioflavin-analogue tracers such as 18F-flutemetamol may be able to fulfill the unmet need of elucidating the presence of amyloid deposition in the heart. Because it binds to the beta-pleated motif of the amyloid fibril due to their similarity to the thioflavin structure, 18F-Flutemetamol could potentially be used to image cardiac amyloidosis (CA)

Study groups in NCT05374564
Study group	Role	What they receive
18F-flutemetamol	Experimental	All clinical trial subjects will receive 18F-flutemetamol Receives: Drug: (18F)Flutemetamol

What is being measured

The primary outcome is the main question the study is designed to answer.

Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET visual uptake scores between the baseline and six-month PET scans
Measured: 6 months
Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET percent maximal counts between the baseline and six-month PET scans
Measured: 6 months
Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET Standardized Uptake Values (SUVs) between the baseline and six-month PET scans
Measured: 6 months
Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET retention index between the baseline and six-month PET scans
Measured: 6 months
Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET Vt between the baseline and six-month PET scans
Measured: 6 months
Determine if treatment with tafamidis reduces 18F-flutemetamol cardiac PET imaging markers
As assessed by dynamic cardiac PET between baseline and 6 months
Measured: 6 months

Secondary outcomes (5)

Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
As determined by ATTR clinical stage baseline and following 6 months of treatment with tafamidis.
Measured: 6 months
Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
As determined by NT-proBNP between baseline and following 6 months of treatment with tafamidis.
Measured: 6 months
Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
As determined by TnT between baseline and following 6 months of treatment with tafamidis.
Measured: 6 months
Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
As determined by echocardiographic wall thickness between baseline and following 6 months of treatment with tafamidis.
Measured: 6 months
Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
As determined by global longitudinal strain between baseline and following 6 months of treatment with tafamidis.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Aug 202214 Nov 2024

First posted16 May 2022
Study start16 Aug 2022
Primary completion14 Nov 2024
Study completion14 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (26)Papers the sponsor has linked to this study.
Other trials for Cardiomyopathies, PrimaryStudies of the same condition, open and under way.
More trials run by Yale UniversityThe 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: Interventional
Phase: Phase 1
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Model description: The proposed study will be a single-arm open-label longitudinal study of 18F-flutemetamol cardiac imaging before/after six months of tafamidis treatment in 12 patients with treatment naïve ATTR cardiac amyloidosis.
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05374564
Sponsor's protocol ID: 2000031407
Status last verified: Jul 2025
First submitted: 10 May 2022
Last updated: 3 Aug 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Maurer MS, Bokhari S, Damy T, Dorbala S, Drachman BM, Fontana M, Grogan M, Kristen AV, Lousada I, Nativi-Nicolau J, Cristina Quarta C, Rapezzi C, Ruberg FL, Witteles R, Merlini G. Expert Consensus Recommendations for the Suspicion and Diagnosis of Transthyretin Cardiac Amyloidosis. Circ Heart Fail. 2019 Sep;12(9):e006075. doi: 10.1161/CIRCHEARTFAILURE.119.006075. Epub 2019 Sep 4.
PubMed 31480867
Gillmore JD, Damy T, Fontana M, Hutchinson M, Lachmann HJ, Martinez-Naharro A, Quarta CC, Rezk T, Whelan CJ, Gonzalez-Lopez E, Lane T, Gilbertson JA, Rowczenio D, Petrie A, Hawkins PN. A new staging system for cardiac transthyretin amyloidosis. Eur Heart J. 2018 Aug 7;39(30):2799-2806. doi: 10.1093/eurheartj/ehx589.
PubMed 29048471
Leuzy A, Savitcheva I, Chiotis K, Lilja J, Andersen P, Bogdanovic N, Jelic V, Nordberg A. Clinical impact of [18F]flutemetamol PET among memory clinic patients with an unclear diagnosis. Eur J Nucl Med Mol Imaging. 2019 Jun;46(6):1276-1286. doi: 10.1007/s00259-019-04297-5. Epub 2019 Mar 26.
PubMed 30915522
Dietemann S, Nkoulou R. Amyloid PET imaging in cardiac amyloidosis: a pilot study using 18F-flutemetamol positron emission tomography. Ann Nucl Med. 2019 Aug;33(8):624-628. doi: 10.1007/s12149-019-01372-7. Epub 2019 May 28.
PubMed 31140154
Papathanasiou M, Kessler L, Carpinteiro A, Hagenacker T, Nensa F, Umutlu L, Forsting M, Brainman A, Kleinschnitz C, Antoch G, Duhrsen U, Schlosser TW, Herrmann K, Rassaf T, Luedike P, Rischpler C. 18F-flutemetamol positron emission tomography in cardiac amyloidosis. J Nucl Cardiol. 2022 Apr;29(2):779-789. doi: 10.1007/s12350-020-02363-2. Epub 2020 Oct 6.
PubMed 33025472
Mockelind S, Axelsson J, Pilebro B, Lindqvist P, Suhr OB, Sundstrom T. Quantification of cardiac amyloid with [18F]Flutemetamol in patients with V30M hereditary transthyretin amyloidosis. Amyloid. 2020 Sep;27(3):191-199. doi: 10.1080/13506129.2020.1760237. Epub 2020 May 13.
PubMed 32400202
Maurer MS, Schwartz JH, Gundapaneni B, Elliott PM, Merlini G, Waddington-Cruz M, Kristen AV, Grogan M, Witteles R, Damy T, Drachman BM, Shah SJ, Hanna M, Judge DP, Barsdorf AI, Huber P, Patterson TA, Riley S, Schumacher J, Stewart M, Sultan MB, Rapezzi C; ATTR-ACT Study Investigators. Tafamidis Treatment for Patients with Transthyretin Amyloid Cardiomyopathy. N Engl J Med. 2018 Sep 13;379(11):1007-1016. doi: 10.1056/NEJMoa1805689. Epub 2018 Aug 27.
PubMed 30145929
Kazi DS, Bellows BK, Baron SJ, Shen C, Cohen DJ, Spertus JA, Yeh RW, Arnold SV, Sperry BW, Maurer MS, Shah SJ. Cost-Effectiveness of Tafamidis Therapy for Transthyretin Amyloid Cardiomyopathy. Circulation. 2020 Apr 14;141(15):1214-1224. doi: 10.1161/CIRCULATIONAHA.119.045093. Epub 2020 Feb 12.
PubMed 32078382
Masri A, Chen H, Wong C, Fischer KL, Karam C, Gellad WF, Heitner SB. Initial Experience Prescribing Commercial Tafamidis, the Most Expensive Cardiac Medication in History. JAMA Cardiol. 2020 Sep 1;5(9):1066-1067. doi: 10.1001/jamacardio.2020.1738.
PubMed 32936265
Gallegos C, Miller EJ. Advances in PET-Based Cardiac Amyloid Radiotracers. Curr Cardiol Rep. 2020 May 19;22(6):40. doi: 10.1007/s11886-020-01284-3.
PubMed 32430600
Ye Q, Wu J, Lu Y, Naganawa M, Gallezot JD, Ma T, Liu Y, Tanoue L, Detterbeck F, Blasberg J, Chen MK, Casey M, Carson RE, Liu C. Improved discrimination between benign and malignant LDCT screening-detected lung nodules with dynamic over static 18F-FDG PET as a function of injected dose. Phys Med Biol. 2018 Sep 6;63(17):175015. doi: 10.1088/1361-6560/aad97f.
PubMed 30095083
Tanskanen M, Peuralinna T, Polvikoski T, Notkola IL, Sulkava R, Hardy J, Singleton A, Kiuru-Enari S, Paetau A, Tienari PJ, Myllykangas L. Senile systemic amyloidosis affects 25% of the very aged and associates with genetic variation in alpha2-macroglobulin and tau: a population-based autopsy study. Ann Med. 2008;40(3):232-9. doi: 10.1080/07853890701842988.
PubMed 18382889
Gonzalez-Lopez E, Gallego-Delgado M, Guzzo-Merello G, de Haro-Del Moral FJ, Cobo-Marcos M, Robles C, Bornstein B, Salas C, Lara-Pezzi E, Alonso-Pulpon L, Garcia-Pavia P. Wild-type transthyretin amyloidosis as a cause of heart failure with preserved ejection fraction. Eur Heart J. 2015 Oct 7;36(38):2585-94. doi: 10.1093/eurheartj/ehv338. Epub 2015 Jul 28.
PubMed 26224076
Donnelly JP, Hanna M, Sperry BW, Seitz WH Jr. Carpal Tunnel Syndrome: A Potential Early, Red-Flag Sign of Amyloidosis. J Hand Surg Am. 2019 Oct;44(10):868-876. doi: 10.1016/j.jhsa.2019.06.016. Epub 2019 Aug 7.
PubMed 31400950
Castano A, Narotsky DL, Hamid N, Khalique OK, Morgenstern R, DeLuca A, Rubin J, Chiuzan C, Nazif T, Vahl T, George I, Kodali S, Leon MB, Hahn R, Bokhari S, Maurer MS. Unveiling transthyretin cardiac amyloidosis and its predictors among elderly patients with severe aortic stenosis undergoing transcatheter aortic valve replacement. Eur Heart J. 2017 Oct 7;38(38):2879-2887. doi: 10.1093/eurheartj/ehx350.
PubMed 29019612

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy
ClinicalTrials.gov ID: NCT05374564
Acronym / sponsor ID: 2000031407
Conditions: Cardiomyopathies, Primary
Keywords: Transthyretin amyloidosis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: Pfizer
Study start: 16 Aug 2022 (actual)
Primary completion: 14 Nov 2024 (actual)
Study completion: 14 Nov 2024 (actual)
First posted: 16 May 2022 (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.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: The proposed study will be a single-arm open-label longitudinal study of 18F-flutemetamol cardiac imaging before/after six months of tafamidis treatment in 12 patients with treatment naïve ATTR cardiac amyloidosis.

Arm	Type	Receives
18F-flutemetamol	Experimental	Drug: (18F)FlutemetamolAll clinical trial subjects will receive 18F-flutemetamol

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

1. Age > 18 years
2. Diagnosis of ATTR cardiac amyloidosis (wild-type or V142I ATTR mutation)
3. Plan for initiation of tafamidis therapy for clinical indications and agree to continue tafamidis during the duration of the study.
4. Stated willingness to comply with all study procedures and availability for the duration of the study
5. Able to understand and sign the informed consent document after the nature of the study has been fully explained.

Key exclusion criteria (8 listed)

1. Primary amyloidosis (AL) or secondary amyloidosis (AA).
2. Prior liver or heart transplantation.
3. Active malignancy or non-amyloid disease with an expected survival of less than 1 year
4. Inability to lie flat for 60 minutes in the PET scanner
5. History of prior treatment for ATTR cardiomyopathy and/or amyloid neuropathy, or decline clinical tafamidis treatment.

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
(18F)FlutemetamolAlso: Vizamyl18F-Flutemetamol binds to β-amyloid plaques and the F-18 isotope produces a positron signal that is detected by a PET scanner. Multiple recent studies have shown that thioflavin-analogue tracers such as 18F-flutemetamol may be able to fulfill the unmet need of elucidating the presence of amyloid deposition in the heart. Because it binds to the beta-pleated motif of the amyloid fibril due to their similarity to the thioflavin structure, 18F-Flutemetamol could potentially be used to image cardiac amyloidosis (CA)	Drug	18F-flutemetamol

Primary outcome

Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
Time frame: 6 months
As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET visual uptake scores between the baseline and six-month PET scans
Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
Time frame: 6 months
As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET percent maximal counts between the baseline and six-month PET scans
Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
Time frame: 6 months
As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET Standardized Uptake Values (SUVs) between the baseline and six-month PET scans
Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
Time frame: 6 months
As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET retention index between the baseline and six-month PET scans
Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
Time frame: 6 months
As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET Vt between the baseline and six-month PET scans
Determine if treatment with tafamidis reduces 18F-flutemetamol cardiac PET imaging markers
Time frame: 6 months
As assessed by dynamic cardiac PET between baseline and 6 months

5 secondary outcomes

Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
Time frame: 6 months
Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
Time frame: 6 months
Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
Time frame: 6 months
Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
Time frame: 6 months
Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
Time frame: 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
Results publication: PubMed 31480867Maurer MS, Bokhari S, Damy T, Dorbala S, Drachman BM, Fontana M, Grogan M, Kristen AV, Lousada I, Nativi-Nicolau J, Cristina Quarta C, Rapezzi C, Ruberg FL, Witteles R, Merlini G. Expert Consensus Recommendations for the Suspicion and Diagnosis of Transthyretin Cardiac Amyloidosis. Circ Heart Fail. 2019 Sep;12(9):e006075. doi: 10.1161/CIRCHEARTFAILURE.119.006075. Epub 2019 Sep 4.
Results publication: PubMed 29048471Gillmore JD, Damy T, Fontana M, Hutchinson M, Lachmann HJ, Martinez-Naharro A, Quarta CC, Rezk T, Whelan CJ, Gonzalez-Lopez E, Lane T, Gilbertson JA, Rowczenio D, Petrie A, Hawkins PN. A new staging system for cardiac transthyretin amyloidosis. Eur Heart J. 2018 Aug 7;39(30):2799-2806. doi: 10.1093/eurheartj/ehx589.
Results publication: PubMed 30915522Leuzy A, Savitcheva I, Chiotis K, Lilja J, Andersen P, Bogdanovic N, Jelic V, Nordberg A. Clinical impact of [18F]flutemetamol PET among memory clinic patients with an unclear diagnosis. Eur J Nucl Med Mol Imaging. 2019 Jun;46(6):1276-1286. doi: 10.1007/s00259-019-04297-5. Epub 2019 Mar 26.
Results publication: PubMed 31140154Dietemann S, Nkoulou R. Amyloid PET imaging in cardiac amyloidosis: a pilot study using 18F-flutemetamol positron emission tomography. Ann Nucl Med. 2019 Aug;33(8):624-628. doi: 10.1007/s12149-019-01372-7. Epub 2019 May 28.
Results publication: PubMed 33025472Papathanasiou M, Kessler L, Carpinteiro A, Hagenacker T, Nensa F, Umutlu L, Forsting M, Brainman A, Kleinschnitz C, Antoch G, Duhrsen U, Schlosser TW, Herrmann K, Rassaf T, Luedike P, Rischpler C. 18F-flutemetamol positron emission tomography in cardiac amyloidosis. J Nucl Cardiol. 2022 Apr;29(2):779-789. doi: 10.1007/s12350-020-02363-2. Epub 2020 Oct 6.
Results publication: PubMed 32400202Mockelind S, Axelsson J, Pilebro B, Lindqvist P, Suhr OB, Sundstrom T. Quantification of cardiac amyloid with [18F]Flutemetamol in patients with V30M hereditary transthyretin amyloidosis. Amyloid. 2020 Sep;27(3):191-199. doi: 10.1080/13506129.2020.1760237. Epub 2020 May 13.
Results publication: PubMed 30145929Maurer MS, Schwartz JH, Gundapaneni B, Elliott PM, Merlini G, Waddington-Cruz M, Kristen AV, Grogan M, Witteles R, Damy T, Drachman BM, Shah SJ, Hanna M, Judge DP, Barsdorf AI, Huber P, Patterson TA, Riley S, Schumacher J, Stewart M, Sultan MB, Rapezzi C; ATTR-ACT Study Investigators. Tafamidis Treatment for Patients with Transthyretin Amyloid Cardiomyopathy. N Engl J Med. 2018 Sep 13;379(11):1007-1016. doi: 10.1056/NEJMoa1805689. Epub 2018 Aug 27.
Results publication: PubMed 32078382Kazi DS, Bellows BK, Baron SJ, Shen C, Cohen DJ, Spertus JA, Yeh RW, Arnold SV, Sperry BW, Maurer MS, Shah SJ. Cost-Effectiveness of Tafamidis Therapy for Transthyretin Amyloid Cardiomyopathy. Circulation. 2020 Apr 14;141(15):1214-1224. doi: 10.1161/CIRCULATIONAHA.119.045093. Epub 2020 Feb 12.
Results publication: PubMed 32936265Masri A, Chen H, Wong C, Fischer KL, Karam C, Gellad WF, Heitner SB. Initial Experience Prescribing Commercial Tafamidis, the Most Expensive Cardiac Medication in History. JAMA Cardiol. 2020 Sep 1;5(9):1066-1067. doi: 10.1001/jamacardio.2020.1738.
Results publication: PubMed 32430600Gallegos C, Miller EJ. Advances in PET-Based Cardiac Amyloid Radiotracers. Curr Cardiol Rep. 2020 May 19;22(6):40. doi: 10.1007/s11886-020-01284-3.
Results publication: PubMed 30095083Ye Q, Wu J, Lu Y, Naganawa M, Gallezot JD, Ma T, Liu Y, Tanoue L, Detterbeck F, Blasberg J, Chen MK, Casey M, Carson RE, Liu C. Improved discrimination between benign and malignant LDCT screening-detected lung nodules with dynamic over static 18F-FDG PET as a function of injected dose. Phys Med Biol. 2018 Sep 6;63(17):175015. doi: 10.1088/1361-6560/aad97f.
Results publication: PubMed 18382889Tanskanen M, Peuralinna T, Polvikoski T, Notkola IL, Sulkava R, Hardy J, Singleton A, Kiuru-Enari S, Paetau A, Tienari PJ, Myllykangas L. Senile systemic amyloidosis affects 25% of the very aged and associates with genetic variation in alpha2-macroglobulin and tau: a population-based autopsy study. Ann Med. 2008;40(3):232-9. doi: 10.1080/07853890701842988.

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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. This study is not recruiting at the moment.

Edward J Miller, MD principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing (18F)Flutemetamol in people with Cardiomyopathies, Primary, run by Yale University 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 3 Aug 2025. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05374564, which also lists 26 linked publications.

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 3 Aug 2025.