Health TrialsbyHealthPanel

[68Ga]Ga-PentixaFor PET/CT in Acute Myocardial Inflammation

ConditionsAcute Cellular Graft RejectionCardiac SarcoidosisMyocarditis Due to Drug
Trial statusTerminated
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohn O. Prior

Reason for stopping the trial:

Recruitment difficulties

About this trial

Acute myocardial inflammation is an heterogenic syndrome involving different clinical pathologies with different outcome. For the purpose of this study protocol, we focuse on three entities of this syndrome, namely the acute cellular cardiac allograft rejection (ACR), cardiac sarcoidosis (CS) and the immune checkpoint inhibitor induced myocarditis (ICIM), for which non-invasive diagnosis remains challenging.

Since accurate diagnosis of myocardial inflammation in an early stage is crucial, this study aims to investigate the accuracy of \[68Ga\]Ga-PentixaFor as a marker of for the presence of inflammatory cells (T-lymphocytes and M1) in described patients.

The identification of a correlation between \[68Ga\]Ga-PentixaFor myocardial accumulation with currently accepted diagnostic tools would open up new ways to non-invasively diagnose acute myocardial inflammation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

signed written informed consent

male or female

age ≥ 18 years

patients with suspicion CS (group II) or ICIM (group III) or in their regular follow-up in their first year after HT (group I)

Disqualifiers

absence of a signed written informed consent

patients aged < 18 years

claustrophobia

myocardial ischemia in non-invasive perfusion test or coronarography in group II and III

Trial design

Design model

Parallel

Treatments tested in this trial

  • [68Ga]Ga-PentixaFor PET/CT

    Drug

    \[68Ga\]Ga-PentixaFor PET/CT

Treatment groups

25 Participants
are divided into 3 treatment groups
Group A: acute cellular cardiac allograft rejectionExperimental treatment 1 intervention
Group B: cardiac sarcoidosisExperimental treatment 1 intervention
Group C: immune checkpoint inhibitor induced myocarditisExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - lesion number

lesion number imaged

Time frame
1 year
2

Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - lesion site

lesion sites imaged

Time frame
1 year
3

Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - SUV

standard uptake value

Time frame
1 year

Secondary outcomes

1

to assess toxicity data

analysis of collected AEs classified according to CTCAE version 5.0

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

John O. Prior

Lead sponsor

University of Lausanne Hospitals

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: