NCT05776212: I-CARE

Quantitative-imaging in Cardiac Transthyretin Amyloidosis

Recruiting now Last updated 27 June 2025

What this trial tests

trial testing 18F-fluoride PET in ATTR-CM in 140 participants. Currently enrolling.

Timeline

25 August 2021

Primary endpoint
30 September 2026

30 September 2026

Quick facts

Lead sponsor	University of Edinburgh
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	140
Start date	25 August 2021
Primary completion	30 September 2026
Estimated completion	30 September 2026
Sites	1 location across Netherlands

Drugs / interventions tested

• 18F-fluoride PET

Conditions studied

• ATTR-CM — all drugs for ATTR-CM →

Sponsor

University of Edinburgh

Who can join

40 and older, any sex, with ATTR-CM. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Hybrid cardiovascular imaging. A clinical consensus statement of the european association of nuclear medicine (EANM) and the european association of cardiovascular imaging (EACVI) of the ESC.
   Caobelli F, Dweck MR, Albano D, Gheysens O, et al · · 2025 · cited 5× · PMID 39436435 · DOI 10.1007/s00259-024-06946-w
2. Feasibility of the absolute quantification and left ventricular segmentation of cardiac sympathetic innervation in wild-type transthyretin amyloidosis cardiomyopathy with [<sup>123</sup>I]-MIBG SPECT/CT: The I-NERVE study.
   Tubben A, Prakken NHJ, Ivashchenko OV, Tingen HSA, et al · · 2025 · cited 3× · PMID 39909199 · DOI 10.1016/j.nuclcard.2025.102146
3. Quantitative imaging in cardiac transthyretin amyloidosis: rationale and design of the i-CARE study.
   Tingen HSA, Balmforth C, Craig N, Tubben A, et al · · 2026 · PMID 42047025 · DOI 10.5603/cj.106172