Immune Checkpoint Inhibitor Therapy for Cancer and Risk of Myocarditis or Cardiomyopathy

NCT06309862 | Recruiting

• 1 other identifier: 5993
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Patients undergoing dual treatment with Immune checkpoint inhibitors (ICI) for various cancers, e.g. melanoma, are at increased risk of developing myocarditis and cardiomyopathy. Currently, only limited data on serial myocardial tissue changes during treatment and whether they predict outcomes are available. Cardiac MRI (CMR) is the reference standard for non-invasive myocardial volumes/function analysis and uniquely characterizes myocardial tissue. Therefore, it may help detect myocardial tissue changes during treatment and help early treatment and prevent adverse cardiac outcomes.

Conditions

Cardio-Oncology; Cardiomyopathy Due to Drug

Keywords

Cardio-Oncology; Immunotherapy; Cardiomyopathy; Cardiac MRI; Myocardial tissue changes

Outcome Measures

Primary Outcomes (3)

• Define changes in CMR tissue and blood biomarkers during ICI treatment.

  The following parameters are investigated to assess for underlying myocardial remodelling and/or inflammation during treatment with ICI. Left ventricular volumes in ml Left ventricular ejection fraction in percentage T1 Mapping: T1 relaxation time in milliseconds T2 Mapping: T2 relaxation time in milliseconds ECV = (1-hematocrit) × (Δ(1/T1myocardium)/Δ(1/T1blood)) in percentage Strain (GCS, GLS, GRS) reported as a percentage, formula =(Max Length-Initial Length)/Initial Length LGE is qualitatively described as categorical variables e.g. epicardial, mid-myocardial, subendocardial or transmural. LGE is quantified as mass in gram and as percentage of the LV mass. High sensitivity troponin 1 nanogram/ mL B-type natriuretic peptide (BNP) nanogram/L High sensitivity CRP in mg/L

  Baseline, 6 weeks and 6 months

• Investigate associations between CMR imaging biomarkers and CMR-defined left ventricular ejection fraction.

  This analysis is to determine if the biomarkers are associated with LVEF changes over time. Left ventricular volumes in ml Left ventricular ejection fraction in percentage T1 Mapping: T1 relaxation time in milliseconds T2 Mapping: T2 relaxation time in milliseconds ECV = (1-hematocrit) × (Δ(1/T1myocardium)/Δ(1/T1blood)) in percentage Strain (GCS, GLS, GRS) reported as a percentage, formula =(Max Length-Initial Length)/Initial Length LGE is qualitatively described as categorical variables e.g. epicardial, mid-myocardial, subendocardial or transmural. LGE is quantified as mass in gram and as percentage of the LV mass.

  Baseline, 6 weeks and 6 months

• Investigate associations between serum biomarkers and CMR-defined left ventricular ejection fraction.

  This analysis is to determine if blood biomarkers are associated with LVEF changes over time. High sensitivity troponin 1 nanogram/ mL B-type natriuretic peptide (BNP) nanogram/L High sensitivity CRP in mg/L

  Baseline, 6 weeks and 6 months

Study Arms (1)

Patients with skin cancer eligible for dual ICI treatment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This pilot study will include 15 patients recruited from Odette Cancer Centre at Sunnybrook Health Sciences Center who have skin cancer and are eligible for immunotherapy treatment.

You may qualify if:

• All patients 18 years of age, or older, with skin cancer and eligible for ICI treatment with a combination of a) nivolumab, b) pembrolizumab, or c) ipilimumab.
• Able to provide informed consent
• Able to travel to SHSC for cardiac imaging.

You may not qualify if:

• Life expectancy equal to, or less than, 12 months
• Participating in another clinical trial
• Treated with ICI in the past
• History of cardiac disease (e.g. heart failure, myocardial infarction, atrial fibrillation, unstable angina)
• Pregnant patients
• Impaired renal function (GFR equal to, or less than, 30mL/min)
• Contraindications for MRI (e.g. pacemaker).

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Center

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Related Publications (20)

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MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Christian Houbois, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Houbois, MD

CONTACT

(416) 480-6100; christian.houbois@sunnybrook.ca

Navpreet Sekhon, MB Bch BAO

CONTACT

(416) 480-6100; navpreet.sekhon@sri.utoronto.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, MD

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: March 13, 2024
• Study Start: June 1, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)