Cardiac Magnetic Resonance Monitoring of Immune Checkpoint Inhibitor-related Cardiotoxicity

NCT06132984 | Recruiting

• 1 other identifier: WestChinaSUH2022228
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective cohort clinical research that analyzes the changes in CMR parameters before and after immune checkpoint inhibitors (ICIs) therapy in patients with gynecologic malignancies. It also evaluates the value of CMR parameters in predicting long-term outcomes. The baseline assessment will be conducted prior to ICIs treatment, followed by multiple assessments during the medication process including within one week prior to cycle 3 , within the week prior to cycle 5 , 1 year after the first dose, and 2 years after the first dose. Assessment will also be conducted after discontinuation of ICIs medication. The assessment includes clinical assessment, CMR imaging, echocardiography, serum cardiac injury biomarkers, etc. Cancer therapy-related cardiac dysfunction (CTRCD), survival, and major adverse cardiac events (MACE) will be followed up.

Conditions

Immune Checkpoint Inhibitors, Cardiotoxicity

Outcome Measures

Primary Outcomes (1)

• cancer therapy-related cardiac dysfunction (CTRCD)

  Any reduction of LVEF to below 50% or a \>10% reduction from baseline falling below the lower limit of normal.

  2 month to 3 years

Secondary Outcomes (1)

• All-cause death; major adverse cardiac events (MACE)

  2 month to 3 years

Study Arms (1)

Patients with gynecologic malignancies who are preparing for ICIs treatment

Diagnostic Test: Cardiac magnetic resonance

Interventions

Cardiac magnetic resonance DIAGNOSTIC_TEST

Cardiac magnetic resonance protocols include cine, non-contrast T1-mapping and T2-mapping.

Patients with gynecologic malignancies who are preparing for ICIs treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with gynecologic malignancies who are preparing for ICIs treatment

You may qualify if:

• \. Female patients aged 18 to 75 years, diagnosed with gynecological malignancies through histology or cytology.
• \. Patients who are preparing for monotherapy or combination therapy with ICIs.
• \. Voluntary signing of informed consent form.
• \. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• \. Expected survival of at least 6 months.

You may not qualify if:

• \. Previously received ICIs treatment.
• \. With allergies or contraindications to ICIs.
• \. Confirmed to be brain metastasis.
• \. Patients who have major surgery within 4 weeks prior to or following the screening period.
• the use of topical or inhaled corticosteroids is permitted;
• short-term (≤7 days) use of corticosteroids for prevention or treatment of non-autoimmune diseases is allowed.
• \. Left ventricular ejection fraction (LVEF) ≤50%, or New York Heart Association functional classification (NYHA) ≥III.
• \. Coronary heart disease, cardiomyopathy, congenital heart disease, valvular heart disease and pericardial diseases with confirmed diagnosis.
• \. Lack of autonomous capacity, or a documented history of mental disease.
• \. MRI contraindications: Pacemakers, neurostimulators, artificial metal heart valves, arterial aneurysm clips, intraocular metallic foreign bodies, inner ear implants, metal prostheses, metal limbs, metal joints, and any other metallic implants or foreign objects; severe hyperthermia patients; claustrophobia; severe respiratory conditions that prevent breath-holding.

Sponsors & Collaborators

• West China Second University Hospital: lead

Study Sites (1)

West China Second University Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

Related Publications (7)

• Zhang L, Zlotoff DA, Awadalla M, Mahmood SS, Nohria A, Hassan MZO, Thuny F, Zubiri L, Chen CL, Sullivan RJ, Alvi RM, Rokicki A, Murphy SP, Jones-O'Connor M, Heinzerling LM, Barac A, Forrestal BJ, Yang EH, Gupta D, Kirchberger MC, Shah SP, Rizvi MA, Sahni G, Mandawat A, Mahmoudi M, Ganatra S, Ederhy S, Zatarain-Nicolas E, Groarke JD, Tocchetti CG, Lyon AR, Thavendiranathan P, Cohen JV, Reynolds KL, Fradley MG, Neilan TG. Major Adverse Cardiovascular Events and the Timing and Dose of Corticosteroids in Immune Checkpoint Inhibitor-Associated Myocarditis. Circulation. 2020 Jun 16;141(24):2031-2034. doi: 10.1161/CIRCULATIONAHA.119.044703. Epub 2020 Jun 15. No abstract available.

  PMID: 32539614 BACKGROUND

• Thavendiranathan P, Zhang L, Zafar A, Drobni ZD, Mahmood SS, Cabral M, Awadalla M, Nohria A, Zlotoff DA, Thuny F, Heinzerling LM, Barac A, Sullivan RJ, Chen CL, Gupta D, Kirchberger MC, Hartmann SE, Weinsaft JW, Gilman HK, Rizvi MA, Kovacina B, Michel C, Sahni G, Gonzalez-Mansilla A, Calles A, Fernandez-Aviles F, Mahmoudi M, Reynolds KL, Ganatra S, Gavira JJ, Gonzalez NS, Garcia de Yebenes Castro M, Kwong RY, Jerosch-Herold M, Coelho-Filho OR, Afilalo J, Zatarain-Nicolas E, Baksi AJ, Wintersperger BJ, Calvillo-Arguelles O, Ederhy S, Yang EH, Lyon AR, Fradley MG, Neilan TG. Myocardial T1 and T2 Mapping by Magnetic Resonance in Patients With Immune Checkpoint Inhibitor-Associated Myocarditis. J Am Coll Cardiol. 2021 Mar 30;77(12):1503-1516. doi: 10.1016/j.jacc.2021.01.050.

  PMID: 33766256 BACKGROUND

• Cadour F, Cautela J, Rapacchi S, Varoquaux A, Habert P, Arnaud F, Jacquier A, Meilhac A, Paganelli F, Lalevee N, Scemama U, Thuny F. Cardiac MRI Features and Prognostic Value in Immune Checkpoint Inhibitor-induced Myocarditis. Radiology. 2022 Jun;303(3):512-521. doi: 10.1148/radiol.211765. Epub 2022 Mar 1.

  PMID: 35230185 BACKGROUND

• Zhang L, Awadalla M, Mahmood SS, Nohria A, Hassan MZO, Thuny F, Zlotoff DA, Murphy SP, Stone JR, Golden DLA, Alvi RM, Rokicki A, Jones-O'Connor M, Cohen JV, Heinzerling LM, Mulligan C, Armanious M, Barac A, Forrestal BJ, Sullivan RJ, Kwong RY, Yang EH, Damrongwatanasuk R, Chen CL, Gupta D, Kirchberger MC, Moslehi JJ, Coelho-Filho OR, Ganatra S, Rizvi MA, Sahni G, Tocchetti CG, Mercurio V, Mahmoudi M, Lawrence DP, Reynolds KL, Weinsaft JW, Baksi AJ, Ederhy S, Groarke JD, Lyon AR, Fradley MG, Thavendiranathan P, Neilan TG. Cardiovascular magnetic resonance in immune checkpoint inhibitor-associated myocarditis. Eur Heart J. 2020 May 7;41(18):1733-1743. doi: 10.1093/eurheartj/ehaa051.

  PMID: 32112560 BACKGROUND

• Faron A, Isaak A, Mesropyan N, Reinert M, Schwab K, Sirokay J, Sprinkart AM, Bauernfeind FG, Dabir D, Pieper CC, Heine A, Kuetting D, Attenberger U, Landsberg J, Luetkens JA. Cardiac MRI Depicts Immune Checkpoint Inhibitor-induced Myocarditis: A Prospective Study. Radiology. 2021 Dec;301(3):602-609. doi: 10.1148/radiol.2021210814. Epub 2021 Sep 28.

  PMID: 34581628 BACKGROUND

• Liu J, Cao Y, Zhu K, Yao S, Yuan M, Kong X, Liu X, Li Y, Cui Y, Han X, Zhou X, Meng R, Shi H. Early evaluation of subclinical cardiotoxicity in patients with lung cancer receiving immune checkpoint inhibitors by cardiovascular magnetic resonance: a prospective observational study. Quant Imaging Med Surg. 2022 Oct;12(10):4771-4785. doi: 10.21037/qims-22-41.

  PMID: 36185042 BACKGROUND

• Ferreira VM, Schulz-Menger J, Holmvang G, Kramer CM, Carbone I, Sechtem U, Kindermann I, Gutberlet M, Cooper LT, Liu P, Friedrich MG. Cardiovascular Magnetic Resonance in Nonischemic Myocardial Inflammation: Expert Recommendations. J Am Coll Cardiol. 2018 Dec 18;72(24):3158-3176. doi: 10.1016/j.jacc.2018.09.072.

  PMID: 30545455 BACKGROUND

MeSH Terms

Conditions

Cardiotoxicity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Central Study Contacts

Lu Ye

CONTACT

86-028-88570418; cltwo@163.com

Study Design

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

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 15, 2023
• Study Start: November 23, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

CN (1)