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

• Sponsor: John O. Prior (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05499637
• Collaborator: (none)
• Enrollment: 69
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 13
• Patients Per Site Per Month: 5.3

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Cellular Graft Rejection; Cardiac Sarcoidosis; Myocarditis Due to Drug	Drug: [68Ga]Ga-PentixaFor PET/CT	Phase 2

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 69 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: acute cellular cardiac allograft rejection [68Ga]Ga-PentixaFor PET/CT	Drug: [68Ga]Ga-PentixaFor PET/CT; [68Ga]Ga-PentixaFor PET/CT; Other Names: no other intervention name
Experimental: cardiac sarcoidosis [68Ga]Ga-PentixaFor PET/CT	Drug: [68Ga]Ga-PentixaFor PET/CT; [68Ga]Ga-PentixaFor PET/CT; Other Names: no other intervention name
Experimental: immune checkpoint inhibitor induced myocarditis [68Ga]Ga-PentixaFor PET/CT	Drug: [68Ga]Ga-PentixaFor PET/CT; [68Ga]Ga-PentixaFor PET/CT; Other Names: no other intervention name

Outcome Measures

Primary Outcome Measures

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

   lesion number imaged

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

   lesion sites imaged

3. Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - SUV [1 year]

   standard uptake value

Secondary Outcome Measures

1. to assess toxicity data [1 year]

   analysis of collected AEs classified according to CTCAE version 5.0

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire Vaudois	Lausanne	Vaud	Switzerland	1011

Sponsors and Collaborators

• John O. Prior

Investigators

• Study Chair: John O Prior, MD, PhD, University of Lausanne Hospitals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: John O. Prior, Head of Nuclear Medicine and Molecular Imaging Department, MD, PhD, University of Lausanne Hospitals
• ClinicalTrials.gov Identifier: NCT05499637
• Other Study ID Numbers: 2022-00425
• First Posted: Aug 12, 2022
• Last Update Posted: Aug 12, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Myocarditis; Sarcoidosis; Inflammation

Study Results

No Results Posted as of Aug 12, 2022