Back to results[68Ga]Ga-PentixaFor PET/CT in Acute Myocardial Inflammation
Primary Purpose
Acute Cellular Graft Rejection, Cardiac Sarcoidosis, Myocarditis Due to Drug
Status
Recruiting
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
[68Ga]Ga-PentixaFor PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Cellular Graft Rejection
Eligibility Criteria
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
Sites / Locations
- Centre Hospitalier Universitaire VaudoisRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
acute cellular cardiac allograft rejection
cardiac sarcoidosis
immune checkpoint inhibitor induced myocarditis
Arm Description
[68Ga]Ga-PentixaFor PET/CT
[68Ga]Ga-PentixaFor PET/CT
[68Ga]Ga-PentixaFor PET/CT
Outcomes
Primary Outcome Measures
Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - lesion number
lesion number imaged
Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - lesion site
lesion sites imaged
Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - SUV
standard uptake value
Secondary Outcome Measures
to assess toxicity data
analysis of collected AEs classified according to CTCAE version 5.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05499637
Brief Title
[68Ga]Ga-PentixaFor PET/CT in Acute Myocardial Inflammation
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2023 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
John O. Prior
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Cellular Graft Rejection, Cardiac Sarcoidosis, Myocarditis Due to Drug
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
69 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
acute cellular cardiac allograft rejection
Arm Type
Experimental
Arm Description
[68Ga]Ga-PentixaFor PET/CT
Arm Title
cardiac sarcoidosis
Arm Type
Experimental
Arm Description
[68Ga]Ga-PentixaFor PET/CT
Arm Title
immune checkpoint inhibitor induced myocarditis
Arm Type
Experimental
Arm Description
[68Ga]Ga-PentixaFor PET/CT
Intervention Type
Drug
Intervention Name(s)
[68Ga]Ga-PentixaFor PET/CT
Other Intervention Name(s)
no other intervention name
Intervention Description
[68Ga]Ga-PentixaFor PET/CT
Primary Outcome Measure Information:
Title
Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - lesion number
Description
lesion number imaged
Time Frame
1 year
Title
Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - lesion site
Description
lesion sites imaged
Time Frame
1 year
Title
Imaging results obtained by [68Ga]Ga-PentixaFor PET/CT - SUV
Description
standard uptake value
Time Frame
1 year
Secondary Outcome Measure Information:
Title
to assess toxicity data
Description
analysis of collected AEs classified according to CTCAE version 5.0
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John O Prior, MD, PhD
Phone
+44795568702
Email
john.prior@chuv.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Christel Kamani, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John O Prior, MD, PhD
Organizational Affiliation
University of Lausanne Hospitals
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John O. Prior, MD, PhD
Phone
+41 (0)21-3144348
Email
john.prior@chuv.ch
First Name & Middle Initial & Last Name & Degree
John O. Prior, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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[68Ga]Ga-PentixaFor PET/CT in Acute Myocardial Inflammation
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