Pilot study to evaluate the accuracy of cardiac PET/CT with [68Ga]Ga-PentixaFor in the diagnosis of three clinical entities of acute myocarditis
Résumé de l'étude
The project aims to study the effectiveness of nuclear imaging PET/CT using a new radiopharmaceutical product, [68Ga]Ga-PentixaFor. We want to investigate whether this single examination provides similar information on the presence of cellular markers of inflammation of the heart muscle, compared to those collected by the multiple standard follow-up examinations of your disease. This new product is not currently approved in Switzerland.
(BASEC)
Intervention étudiée
Participation in the study consists of a PET/CT examination with [68Ga]Ga-PentixaFor: the injection of the radiopharmaceutical product is followed by a one-hour rest period and the acquisition of images for about 25 minutes.
All patients will have the same PET/CT imaging with [68Ga]Ga-PentixaFor.
The standard follow-up and standard examinations related to the pathology will be carried out in a standard manner and will differ by patient group, being adapted to each pathology.
(BASEC)
Maladie en cours d'investigation
Acute myocarditis: patients in follow-up during their first year post heart transplantation OR patients with clinical suspicion of cardiac sarcoidosis OR patients with clinical suspicion of immunotherapy-induced myocarditis
(BASEC)
- signature of consent - aged ≥ 18 years - patients in the first year following heart transplantation (group I), patients with suspected cardiac sarcoidosis based on clinical findings (group II) and patients with immunotherapy-induced myocarditis (group III) - standard follow-up in the cardiology department of CHUV (BASEC)
Critères d'exclusion
- claustrophobia - documented myocardial ischemia by non-invasive testing or coronary angiography - unstable clinical conditions - pregnant or breastfeeding women - women with intent to become pregnant during the study (BASEC)
Lieu de l’étude
Lausanne
(BASEC)
Sponsor
CHUV
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Christine Geldhof
+41 79 556 01 47
christine.geldhof@clutterchuv.chCHUV
(BASEC)
Informations générales
University of Lausanne Hospitals,
+44795568702;+41 (0)21-3144348
john.prior@chuv.ch(ICTRP)
Informations générales
University of Lausanne Hospitals
+44795568702+41 (0)21-3144348
john.prior@chuv.chjohn.prior@chuv.ch(ICTRP)
Informations scientifiques
University of Lausanne Hospitals,
+44795568702;+41 (0)21-3144348
john.prior@chuv.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique du Vaud
(BASEC)
Date d'approbation du comité d'éthique
06.10.2022
(BASEC)
Identifiant de l'essai ICTRP
NCT05499637 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
cf section 1 (BASEC)
Titre académique
Pilot Study to Evaluate the Accuracy of [68Ga]Ga-PentixaFor PET/CT in the Diagnosis of Three Clinical Entities of Acute Myocardial Inflammation (ICTRP)
Titre public
[68Ga]Ga-PentixaFor PET/CT in Acute Myocardial Inflammation (ICTRP)
Maladie en cours d'investigation
Acute Cellular Graft RejectionCardiac SarcoidosisMyocarditis Due to Drug (ICTRP)
Intervention étudiée
Drug: [68Ga]Ga-PentixaFor PET/CT (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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 (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - lesion number;Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - lesion site;Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - SUV (ICTRP)
to assess toxicity data (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
John O Prior, MD, PhD;John O Prior, MD, PhD;John O. Prior, MD, PhD, john.prior@chuv.ch, +44795568702;+41 (0)21-3144348, University of Lausanne Hospitals, (ICTRP)
ID secondaires
2022-00425 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/study/NCT05499637 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible