Cardiac Magnetic Resonance for Diagnosis, Treatment Guidance and Prognosis of Cardiac Masses (CMR)

The goal of this observational study is to explore the diagnostic accuracy, treatment-guiding value, and prognostic predictive utility of cardiovascular magnetic resonance (CMR) in patients with suspected or confirmed cardiac masses. Cardiac masses include neoplastic (primary tumors, secondary metastases) and non-neoplastic (thrombi, pericardial cysts, inflammatory pseudotumors) lesions-primary tumors are extremely rare (incidence: 0.0017%-0.03%), with 75% benign (myxoma accounting for 40%-50%) and 25% malignant (predominantly angiosarcoma), while secondary metastases are 20-40 times more common. Non-neoplastic masses like thrombi are linked to atrial fibrillation and heart failure, with thromboembolism as a fatal complication. Due to non-specific symptoms (chest pain, dyspnea) and pathological heterogeneity, accurate lesion differentiation and outcome prediction remain clinical challenges.

CMR serves as the "silver standard" for non-invasive assessment of cardiac masses, leveraging superior soft tissue resolution, multi-planar imaging, and multi-parameter tissue characterization (T1/T2 weighted imaging, FPP, LGE, T1/T2 mapping, ECV). Multicenter studies confirm its 98.4% overall diagnostic accuracy and 98.4% benign/malignant differentiation accuracy, with excellent consistency with histopathology (Cohen's Kappa = 0.88). However, existing research is mostly retrospective with small samples, lacking systematic validation of quantitative CMR indicators-gaps this study addresses.

The main questions it aims to answer are:

Does CMR (qualitative + quantitative indicators) accurately differentiate neoplastic/non-neoplastic and benign/malignant cardiac masses (gold standard: histopathology or long-term follow-up)? Can CMR features (size, margin, infiltration, enhancement pattern, T1/T2 values, ECV) guide treatment selection (surgical resection, interventional therapy, medical treatment, conservative follow-up)? Do specific CMR indicators independently predict long-term outcomes (all-cause mortality, recurrence, thromboembolism) in patients with cardiac masses? Participants will include patients who undergo CMR for suspected/confirmed cardiac masses Patients receiving routine CMR as part of clinical care will have their CMR images analyzed, treatment plans recorded, and be followed up for 3 years via outpatient visits, telephone, or electronic medical records (at 1, 3, 6, 12, 24, 36 months) to collect survival status, recurrence, cardiac function changes, and adverse events.

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Key information

Conditions

Cardiac Masses Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Suspected or confirmed cardiac masses by imaging examinations (e.g., echocardiography, computed tomography).
Scheduled for or have completed cardiovascular magnetic resonance (CMR) examination.

Exclusion criteria

Unable to obtain diagnostic-quality cardiac CMR images (due to uncontrollable claustrophobia, severe motion/arrhythmia artifacts, uncorrectable scanning failures).
Unable to determine the nature of the cardiac mass (inaccessible to histopathological examination, unclear diagnosis via comprehensive clinical evaluation).
Unable to obtain follow-up information (lost to follow-up, refusal of follow-up, unclear outcome attribution due to severe concurrent diseases).

Treatment and study plan

CMR-Based Tissue Characterization + Lesion-Specific Clinical Management

Diagnostic Test

For the neoplastic cohort: Standardized 3.0T CMR (conventional sequences + quantitative mapping + FPP + LGE) to characterize tumor nature (benign/malignant, primary/metastatic) and guide clinical management (surgical resection, chemotherapy, radiotherapy, or surveillance). For the non-neoplastic cohort: CMR to confirm lesion type (thrombus, cyst, etc.) and guide targeted treatment (anticoagulation, surgical excision, anti-inflammatory therapy, or conservative follow-up). All patients complete 3-year long-term follow-up to assess outcomes.

CMR-Based Malignancy Differentiation + Tumor-Nature-Specific Clinical Management

Diagnostic Test

For the benign cohort: Standardized 3.0T CMR (conventional sequences + quantitative mapping + FPP + LGE) to confirm benign nature and guide clinical management (curative surgical resection for symptomatic/large lesions or long-term surveillance for asymptomatic small lesions). For the malignant cohort: CMR to assess tumor invasiveness, metastasis, and cardiac function impact, further guiding individualized treatment (radical resection, adjuvant chemotherapy/radiotherapy, palliative therapy, or systemic therapy for primary tumors). All patients complete 3-year long-term follow-up to monitor recurrence and survival outcomes.

CMR-Based Prognostic Stratification + Outcome-Targeted Follow-Up

Diagnostic Test

For both cohorts: Baseline standardized 3.0T CMR evaluation (conventional sequences + quantitative mapping + FPP + LGE) to collect potential prognostic indicators (lesion size, infiltration extent, enhancement pattern, T1/T2 values, ECV). During 3-year follow-up, regular assessments (outpatient visits, CMR re-evaluation, telephone follow-up) are conducted to monitor outcomes. The intervention focuses on analyzing the correlation between baseline CMR features and prognostic status (favorable/unfavorable) to validate CMR's predictive value for long-term outcomes.

Primary outcomes

Nature of the mass

Time frame: 5 years

The diagnosis of the nature of tumors was established based on histopathology results when these results were available, or alternatively based on the presence of distant metastasis confirmed during follow-up.
All Because of Death

Time frame: 5 years

This endpoint is formally referred to as All-Cause Mortality in clinical research; it denotes the occurrence of death in a study participant from any underlying reason (regardless of whether the cause is related to the study's target disease, intervention, or unrelated comorbidities/incidents) during the predefined observation period.

The approaches of collection of all-cause mortality data outlined below:

Study teams conduct scheduled follow-ups (e.g., in-clinic visits, telephone check-ins, or remote patient monitoring) at predefined intervals (every 6 months) to inquire about the participant's survival status. Supplemental Verification via Inpatient Record Systems involves querying the hospital's inpatient electronic health record system if the participant is admitted to a hospital during the follow-up period.

Sponsors and collaborators

Lead sponsor

Minjie Lu

Other

Registry information

Official study title

Clinical Utility of CMR for Diagnosis, Treatment Guidance and Prognostication of Cardiac Masses

Important dates

Study start: 2008
Primary completion: 2035
Study completion: 2035
First posted: Jan 13, 2026
Registry last updated: Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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