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NCT Number: NCT05499637

[68Ga]Ga-PentixaFor PET/CT in 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location status: Recruiting

Location contact

John O. Prior, MD, PhD

CONTACT

[email protected]

+41 (0)21-3144348

John O. Prior, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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:
  • 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

Treatment and study plan

[68Ga]Ga-PentixaFor PET/CT

Drug

[68Ga]Ga-PentixaFor PET/CT

Other names: no other intervention name

Primary outcomes

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

    Time frame: 1 year

    lesion number imaged

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

    Time frame: 1 year

    lesion sites imaged

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

    Time frame: 1 year

    standard uptake value

Secondary outcomes

  1. to assess toxicity data

    Time frame: 1 year

    analysis of collected AEs classified according to CTCAE version 5.0

Study contacts

Contact information is provided by the study sponsor or research team.

Christel Kamani, MD

CONTACT

John O Prior, MD, PhD

CONTACT

[email protected]

+44795568702

Sponsors and collaborators

Lead sponsor

John O. Prior

Other

Registry information

Official study title

Pilot Study to Evaluate the Accuracy of [68Ga]Ga-PentixaFor PET/CT in the Diagnosis of Three Clinical Entities of Acute Myocardial Inflammation

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Aug 12, 2022
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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