18F-Flutemetamol PET Imaging for Cardiomyopathy

Overseen By Julie Holub

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Yale University

Must be taking: Tafamidis

Disqualifiers: Primary amyloidosis, Secondary amyloidosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 6 months

12 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants to start and continue taking tafamidis during the study. The protocol does not specify if you need to stop other medications.

What data supports the effectiveness of the drug 18F-Flutemetamol for cardiomyopathy?

Research suggests that 18F-Flutemetamol PET imaging can successfully detect cardiac amyloidosis, a condition related to cardiomyopathy, as demonstrated in a case study. This drug is also effective in imaging amyloid deposits in Alzheimer's disease, indicating its potential usefulness in detecting similar deposits in the heart. ^{1 2 3 4 5}

How does the drug 18F-Flutemetamol differ from other treatments for cardiomyopathy?

18F-Flutemetamol is unique because it is a PET imaging agent originally used to detect amyloid plaques in the brain for Alzheimer's diagnosis, and it is now being explored for its potential to detect amyloid deposits in the heart, which could help in diagnosing cardiac amyloidosis, a form of cardiomyopathy. ^{1 2 3 4 6}

What is the purpose of this trial?

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 decline. This study is designed to evaluate a novel use for 18F-Flutemetamol in cardiac amyloidosis.

Research Team

Edward Miller, MD

Principal Investigator

Yale University

Eligibility Criteria

This trial is for adults over 18 with ATTR cardiac amyloidosis, who are starting tafamidis therapy and can commit to the study duration. Participants must be able to lie flat for an hour and use contraception if of childbearing potential. Those with other types of amyloidosis, past transplants, active cancers, or known allergies to the test drug's components cannot join.

Inclusion Criteria

I agree to use birth control during and 30 days after the treatment.

Able to understand and sign the informed consent document after the nature of the study has been fully explained

I agree to start and continue tafamidis therapy for the study duration.

Exclusion Criteria

I have had a liver or heart transplant.

Pregnancy or lactation

I have been diagnosed with primary or secondary amyloidosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline 18F-flutemetamol PET imaging to assess initial disease burden

1 week

1 visit (in-person)

Treatment

Participants receive tafamidis treatment and undergo 18F-flutemetamol PET imaging

6 months

Regular visits for tafamidis administration and monitoring

Follow-up

Participants are monitored for changes in 18F-flutemetamol PET imaging markers and clinical response

4 weeks

Treatment Details

Interventions

• (18F)Flutemetamol

Trial Overview (18F)Flutemetamol (Vizamyl), a radioactive agent used in brain PET scans for Alzheimer's diagnosis, is being tested for its novel application in detecting heart issues related to ATTR cardiomyopathy using PET imaging technology.

Participant Groups

Group I: 18F-flutemetamol Experimental Treatment 1 Intervention

All clinical trial subjects will receive 18F-flutemetamol

(18F)Flutemetamol is already approved in United States, European Union for the following indications:

Approved in United States as Vizamyl for:

• Estimating 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 decline

Approved in European Union as Vizamyl for:

• Estimating 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 decline

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Findings from Research

F-flutemetamol PET/CT successfully imaged cardiac light chain amyloidosis in a 56-year-old man, indicating its potential as a diagnostic tool for this condition.

Unlike a matched healthy volunteer, the patient showed specific heart uptake, suggesting that F-flutemetamol may provide a practical advantage over other imaging agents, but further trials are needed to confirm its efficacy in cardiac amyloidosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is 18F-flutemetamol PET/CT able to reveal cardiac amyloidosis? Lhommel, R., Sempoux, C., Ivanoiu, A., et al.[2018]

The review highlights the clinical utility of the PET ligand [(18)F]flutemetamol in detecting β-amyloid deposition in Alzheimer's disease, which can aid in differentiating AD from other neurodegenerative disorders.

[(18)F]flutemetamol may also play a significant role in clinical trials for anti-amyloid therapies by helping select appropriate subjects and measuring treatment effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging β-amyloid using [(18)F]flutemetamol positron emission tomography: from dosimetry to clinical diagnosis. Heurling, K., Leuzy, A., Zimmer, ER., et al.[2019]

A study involving post-mortem myocardial tissue from 29 subjects with cardiac amyloidosis showed that cyano-flutemetamol specifically binds to amyloid deposits, indicating its potential as a diagnostic tool for imaging myocardial amyloid using PET scans.

The binding of cyano-flutemetamol was significantly correlated with echocardiographic measures of heart structure, suggesting that it could help assess the severity of cardiac amyloidosis in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The flutemetamol analogue cyano-flutemetamol detects myocardial AL and ATTR amyloid deposits: a post-mortem histofluorescence analysis. Abrahamson, EE., Padera, RF., Davies, J., et al.[2023]

Flutemetamol (18F) is a new PET imaging agent that effectively detects β-amyloid deposits in the brain, which is crucial for diagnosing Alzheimer's disease, showing high sensitivity and specificity in phase III trials.

The agent has a similar safety profile and metabolism to existing imaging tracers, allowing for reliable quantification of amyloid plaque pathology in patients with Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flutemetamol (18F): a β-amyloid positron emission tomography tracer for Alzheimer's and dementia diagnosis. de Lartigue, J.[2022]

In a study involving 61 cognitively unimpaired adults, the 18F-flutemetamol PET ligand demonstrated higher uptake in white matter hyperintensities (WMH) and normal-appearing white matter (NAWM) compared to the 11C-Pittsburgh compound B (11C-PiB), indicating its potential for better imaging of white matter integrity.

Both 11C-PiB and 18F-flutemetamol showed similar patterns in differentiating WMH from NAWM across different age groups, but 18F-flutemetamol's longer half-life and higher binding potential make it a more practical option for studying conditions like multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of 11C-Pittsburgh Compound B and 18F-Flutemetamol White Matter Binding in PET. Zeydan, B., Schwarz, CG., Przybelski, SA., et al.[2023]

The study demonstrated that [(18)F]flutemetamol has a pharmacokinetic profile similar to [(11)C]Pittsburgh compound B, showing effective brain uptake and binding to β-amyloid deposits in a transgenic mouse model of Alzheimer's disease.

Despite its potential as a PET tracer for imaging β-amyloid, the high lipophilicity of [(18)F]flutemetamol may complicate data analysis in small-animal imaging, which is an important consideration for its use in research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of [¹⁸F]flutemetamol in wild-type rodents and its binding to beta amyloid deposits in a mouse model of Alzheimer's disease. Snellman, A., Rokka, J., Lopez-Picon, FR., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Is 18F-flutemetamol PET/CT able to reveal cardiac amyloidosis? [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

Imaging β-amyloid using [(18)F]flutemetamol positron emission tomography: from dosimetry to clinical diagnosis. [2019]

3. England pubmed.ncbi.nlm.nih.gov

The flutemetamol analogue cyano-flutemetamol detects myocardial AL and ATTR amyloid deposits: a post-mortem histofluorescence analysis. [2023]

4. Spain pubmed.ncbi.nlm.nih.gov

Flutemetamol (18F): a β-amyloid positron emission tomography tracer for Alzheimer's and dementia diagnosis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Comparison of 11C-Pittsburgh Compound B and 18F-Flutemetamol White Matter Binding in PET. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of [¹⁸F]flutemetamol in wild-type rodents and its binding to beta amyloid deposits in a mouse model of Alzheimer's disease. [2021]