Effect of Radiotherapy on ATTR Cardiac Amyloidosis : a Proof of Concept Study
NCT ID: NCT03397810
Last Updated: 2021-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
36 participants
INTERVENTIONAL
2019-03-15
2026-02-28
Brief Summary
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Detailed Description
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Measurements of effect will be assessed at 12 weeks by:
Amyloid PET Cardiac MRI with administration of gadolinium and ultrasound A blood venous sample (cardiac biomarkers) Quality of life assessments
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Singe arm
Subjects will receive a low dose radiotherapy focused to the heart
low dose radiotherapy
10 Gy in 5 fractions of 2 Gy on 5 consecutive days
Interventions
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low dose radiotherapy
10 Gy in 5 fractions of 2 Gy on 5 consecutive days
Eligibility Criteria
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Inclusion Criteria
* Dyspnoea on exertion (NYHA II or more).
* Stable elevated cardiac enzymes (ultra sensitive Troponin T \> 14 ng/L on consecutive sampling or BNP \> 100pg/mL)
* A positive 99mTc-DPD cardiac scintigraphy (Grade 2 and 3) suggesting an ATTR or wt amyloidosis.
* Additional imaging also compatible with cardiac amyloidosis (cardiac ultrasound showing basal to apical longitudinal strain gradient and magnetic resonance imaging with elevated T1 value or extracellular volume).
* Compliance with the informed consent as attested by its signature.
* Positive baseline 18F-Florbetapir imaging, as assessed visually and quantitatively by a Tissue to Background Ratio \> 1.45
Exclusion Criteria
* Previous external beam radiotherapy including the chest.
* Claustrophobia
* Presence of internal non-MR compatible devices
* Creatinine glomerular filtration rate \< 30 ml/min
* Oncologic disease (excluding skin cancer) active or in remission from less than 5 years
65 Years
ALL
No
Sponsors
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Philippe Meyer
OTHER
Responsible Party
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Philippe Meyer
Principal Investigator
Locations
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Geneva University Hospital
Geneva, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2017-00640
Identifier Type: -
Identifier Source: org_study_id
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