Acute Cellular Graft RejectionPhase 2NCT05499637
[68Ga]Ga-PentixaFor PET/CT in Acute Myocardial Inflammation
A Phase 2 study testing [68Ga]Ga-PentixaFor PET/CT in people with Acute Cellular Graft Rejection and Cardiac Sarcoidosis, run by John O. Prior at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Cellular Graft Rejection, Cardiac Sarcoidosis, Myocarditis Due to Drug
- What is being tested?
- [68Ga]Ga-PentixaFor PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Jan 2023to 14 Sep 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- SOC clinical follow-up at the cardiology department in CHUV.
Who cannot join
- The presence of any one of the following exclusion criteria will lead to exclusion of the participant:
- 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
- clinically unstable cardiovascular conditions, including:
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- clinically unstable brady-tachyarrhythmia
- severe and symptomatic hypo- or hypertension with documented systolic blood pressure < 90 mmHg or ≥220 mmHg respectively
- cardiogenic shock.
- women who are pregnant or breast feeding
- intention to become pregnant during the course of the study in group II
- previous enrolment into the current study
- moderate to severe renal insufficiency (GFR < 45 mL/min/1,73 m2), with contra-indication to the administration of Gadolinium in group II and III
- enrollment of the investigator, his/her family members, employees and other dependent persons
- history of any disease or relevant physical or psychiatric condition or abnormal physical finding which may interfere with the study objectives at the investigator judgment
- insufficient knowledge of project language, inability to give consent or to follow procedures
- the patient makes use of his/her "right not to know" and refuses to be informed about incidental findings
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
About this study
Official title: Pilot Study to Evaluate the Accuracy of [68Ga]Ga-PentixaFor PET/CT in the Diagnosis of Three Clinical Entities of Acute Myocardial Inflammation
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.
Read the detailed description
Imaging will consist of administration of maximum 50 µg IV PentixaFor, labelled with 150 ±15 MBq of 68Ga, as bolus injection 60 ±15 minutes prior PET/CT
- Being tested
- [68Ga]Ga-PentixaFor PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-PentixaFor PET/CTDrug
Also called no other intervention name
[68Ga]Ga-PentixaFor PET/CT
| Study group | Role | What they receive |
|---|---|---|
| acute cellular cardiac allograft rejection | Experimental | [68Ga]Ga-PentixaFor PET/CT Receives: Drug: [68Ga]Ga-PentixaFor PET/CT |
| cardiac sarcoidosis | Experimental | [68Ga]Ga-PentixaFor PET/CT Receives: Drug: [68Ga]Ga-PentixaFor PET/CT |
| immune checkpoint inhibitor induced myocarditis | Experimental | [68Ga]Ga-PentixaFor PET/CT Receives: Drug: [68Ga]Ga-PentixaFor PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - lesion number
lesion number imaged
Measured: 1 year
Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - lesion site
lesion sites imaged
Measured: 1 year
Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - SUV
standard uptake value
Measured: 1 year
Secondary outcomes (1)
to assess toxicity data
analysis of collected AEs classified according to CTCAE version 5.0
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start17 Jan 2023
- Primary completion14 Sep 2026
- Study completion14 Sep 2026
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Cellular Graft RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- John O. Prior
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John O. Prior, University of Lausanne Hospitals
- Investigators
- John O Prior, MD, PhD, Study chair, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499637
- Sponsor's protocol ID
- 2022-00425
- Status last verified
- Oct 2026
- First submitted
- 22 Jun 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No