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

Minjie Lu

Status: Invitation-only

Conditions: Cardiac Masses

Treatments: Diagnostic Test: CMR-Based Malignancy Differentiation + Tumor-Nature-Specific Clinical Management; Diagnostic Test: CMR-Based Tissue Characterization + Lesion-Specific Clinical Management; Diagnostic Test: CMR-Based Prognostic Stratification + Outcome-Targeted Follow-Up

Study type: Observational

Funder types: Other

Identifiers

NCT07335770

CMR_Cardiac Mass

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

2,000 participants in 6 patient groups

Neoplastic Cardiac Mass Cohort

Description:

Patients with histopathologically confirmed or clinically diagnosed neoplastic cardiac masses, including primary cardiac tumors (benign: myxoma, fibroma, rhabdomyoma; malignant: angiosarcoma, rhabdomyosarcoma) and secondary cardiac metastases (from lung cancer, breast cancer, hematological malignancies, etc.). All patients undergo complete CMR evaluation (conventional sequences + quantitative mapping + FPP + LGE) and long-term follow-up.

Treatment:

Diagnostic Test: CMR-Based Tissue Characterization + Lesion-Specific Clinical Management

Non-Neoplastic Cardiac Mass Cohort

Description:

Patients with confirmed non-neoplastic cardiac masses, including cardiac thrombi (diagnosed by anticoagulation response or histopathology), pericardial cysts, inflammatory pseudotumors, etc. All patients complete CMR examinations and follow-up as required.

Treatment:

Diagnostic Test: CMR-Based Tissue Characterization + Lesion-Specific Clinical Management

Benign Cardiac Mass Cohort

Description:

Patients with histopathologically confirmed benign cardiac masses, including myxoma, fibroma, rhabdomyoma, lipoma, pericardial cyst, etc. All undergo complete CMR evaluation and long-term follow-up.

Treatment:

Diagnostic Test: CMR-Based Malignancy Differentiation + Tumor-Nature-Specific Clinical Management

Malignant Cardiac Mass Cohort

Description:

Patients with confirmed malignant cardiac masses, including primary malignant tumors (angiosarcoma, rhabdomyosarcoma) and secondary cardiac metastases (from lung cancer, breast cancer, hematological malignancies, etc.). All complete CMR examinations and follow-up as required.

Treatment:

Diagnostic Test: CMR-Based Malignancy Differentiation + Tumor-Nature-Specific Clinical Management

Favorable Prognosis Cohort

Description:

Patients with cardiac masses (neoplastic/non-neoplastic) who are alive without lesion recurrence, major adverse cardiac events (thromboembolism, heart failure), or progressive cardiac dysfunction at the 3-year follow-up.

Treatment:

Diagnostic Test: CMR-Based Prognostic Stratification + Outcome-Targeted Follow-Up

Unfavorable Prognosis Cohort

Description:

Patients with cardiac masses (neoplastic/non-neoplastic) who experience all-cause death, lesion recurrence, major adverse cardiac events, or progressive cardiac dysfunction during the 3-year follow-up.

Treatment:

Diagnostic Test: CMR-Based Prognostic Stratification + Outcome-Targeted Follow-Up