Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-29 @ 4:35 AM
Study NCT ID:
NCT05776212
Status:
RECRUITING
Last Update Posted:
2025-06-27
First Post:
2023-01-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantitative-imaging in Cardiac Transthyretin Amyloidosis
Sponsor:
University of Edinburgh
Organization:
Study Overview
Official Title:
Quantitative-imaging in Cardiac Transthyretin Amyloidosis
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
I-CARE
Brief Summary:
Transthyretin amyloid cardiomyopathy (ATTR-CM), is a heart muscle disease that's stops the heart muscle working properly. With an ageing population, it is increasingly common but untreated, it has a poor prognosis. Several novel expensive treatments have become available, although we do not understand exactly how they work and why some patients respond, and others do not. The challenge is to develop better methods for monitoring the effects of these treatments, maximizing their benefits and cost-effectiveness. In I-CARE we aim to bring a new imaging technique, named 18F-fluoride PET, to the clinic and thereby improve the care of patients with ATTR-CM.
Hypotheses:
1. A delayed imaging protocol and state-of-the-art PET motion correction will optimise 18F-fluoride imaging in ATTR-CM and provide a clear threshold in myocardial TBR values for the diagnosis of ATTR-CM.
2. Optimised 18F-fluoride PET will provide a quantitative marker of the ATTR-CM burden that will allow disease progression and treatment response to be tracked.
3. Myocardial 18F-fluoride TBR values will reduce in patients responding to tafamidis treatment and increase in non-responders and patients not receiving therapy
Hypotheses:
1. A delayed imaging protocol and state-of-the-art PET motion correction will optimise 18F-fluoride imaging in ATTR-CM and provide a clear threshold in myocardial TBR values for the diagnosis of ATTR-CM.
2. Optimised 18F-fluoride PET will provide a quantitative marker of the ATTR-CM burden that will allow disease progression and treatment response to be tracked.
3. Myocardial 18F-fluoride TBR values will reduce in patients responding to tafamidis treatment and increase in non-responders and patients not receiving therapy
Detailed Description:
Studies have shown that there is calcium deposition in the heart muscle in ATTR-CM but exactly how this happens is not completely understood. Tafamidis, a new drug treatment, has shown improved outcomes for patients with ATTRCM by reducing hospitalisations and improving survival but the mechanism of action of Tafamidis is also not clearly understood yet. 18F-Fluoride PET/CT offers the opportunity to study this phenomenon of calcium deposition in ATTR-CM in more detail and study and track response to the new drug treatment. This will also provide an opportunity to investigate whether tafamidis therapy reduces calcium deposition in the heart muscle associated with ATTR-CM.
We have designed the study specifically to answer our research questions as best as possible, whilst keeping burdens to the patients at a minimum.
To the best of our knowledge this will be the first human study to utilise this imaging technique to assess and track response to the new drug treatment in ATTR-CM. We hope that it will provide major insights in to complex interactions at play, that could drive forward the development of novel therapeutic strategies for patients with ATTR-CM.
We have designed the study specifically to answer our research questions as best as possible, whilst keeping burdens to the patients at a minimum.
To the best of our knowledge this will be the first human study to utilise this imaging technique to assess and track response to the new drug treatment in ATTR-CM. We hope that it will provide major insights in to complex interactions at play, that could drive forward the development of novel therapeutic strategies for patients with ATTR-CM.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2020-003350-72 | EUDRACT_NUMBER | None | View |