Cardiac Magnetic Resonance for Diagnosis, Treatment Guidance and Prognosis of Cardiac Masses (CMR)
NCT07335770 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 2000
Last updated 2026-01-13
Summary
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.
Conditions
- Cardiac Masses
Interventions
- DIAGNOSTIC_TEST
-
CMR-Based Tissue Characterization + Lesion-Specific Clinical Management
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.
- DIAGNOSTIC_TEST
-
CMR-Based Malignancy Differentiation + Tumor-Nature-Specific Clinical Management
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.
- DIAGNOSTIC_TEST
-
CMR-Based Prognostic Stratification + Outcome-Targeted Follow-Up
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.
Sponsors & Collaborators
-
Minjie Lu
lead OTHER
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-01-01
- Primary Completion
- 2035-11-30
- Completion
- 2035-12-31
More Related Trials
-
Quantitative Cardiac Parametric Mapping
NCT02855554 ·Status: RECRUITING ·Phase: NA
-
Using Cardiac MRI to Predict Outcomes in Patients With STEMI
NCT07072858 ·Status: RECRUITING
-
Research on Diagnosis and Prognosis of Myocardial Ischemia Level Using Magnetocardiography
NCT05718206 ·Status: UNKNOWN ·Phase: NA
-
Magnetocardiography in the Accurate Identification of Severe Coronary Lesions and Myocardial Necrosis
NCT05392712 ·Status: RECRUITING ·Phase: NA
-
Magnetocardiography (MCG) in Subjects Undergoing CT Angiography (CTA)
NCT00574561 ·Status: WITHDRAWN
-
Edema and Fibrosis CMR Imaging in Cardiomyopathy
NCT03534726 ·Status: ACTIVE_NOT_RECRUITING
-
Safety and Efficacy of MCG for Diagnosing Coronary Heart Disease
NCT00170027 ·Status: COMPLETED ·Phase: PHASE3
-
Use of Magnetic Field Mapping in the Evaluation of Patients With Hypertrophic Heart Disease (Thick Heart Muscle)
NCT00574821 ·Status: WITHDRAWN
-
Cardiac Magnetic Resonance Assessment for Heart Failure With Preserved Ejection Fraction
NCT04063579 ·Status: COMPLETED ·Phase: NA
-
International T1 Multicentre CMR Outcome Study
NCT02407197 ·Status: COMPLETED
-
Magnetic Resonance Imaging in Myocarditis
NCT02177630 ·Status: COMPLETED
-
Magnetocardiography in the Accurate Identification of Myocardial Infarction
NCT05896826 ·Status: RECRUITING
-
Magnetocardiography (MCG) in the Diagnosis of Chest Pain Syndrome
NCT00572949 ·Status: WITHDRAWN
-
Inter-field Strength Agreement of CMR Derived Strain
NCT04475627 ·Status: COMPLETED
-
Diagnosis of Myocardial Ischemia With MCG Using SPECT as a Reference Standard
NCT06255769 ·Status: RECRUITING
-
EARLY Assessment of MYOcardial Tissue Characteristics in OBESITY (EARLY-MYO-OBESITY)
NCT05277779 ·Status: COMPLETED
-
Quantification of Mitral Regurgitation Using 4D MRI Flow : Comparison With 2D MRI Flow and Echocardiography Using the Evolution of Left Ventricular Remodeling as a Reference
NCT07066904 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
CMR-Based Prognostic Study in Patients With Cardiac Implantable Electronic Devices
NCT07336225 ·Status: RECRUITING
-
The Role of Cardiovascular Magnetic Resonance in Patients With Non-ST- Elevation- Myocardial Infarction
NCT05751057 ·Status: UNKNOWN ·Phase: NA
-
Artificial Intelligence in New Cardiac MR Markers for Congenital Heart Disease
NCT05979870 ·Status: ENROLLING_BY_INVITATION
-
Automated Reports Generation of Cardiovascular Magnetic Resonance Imaging
NCT07340762 ·Status: ACTIVE_NOT_RECRUITING
-
MCG is Clinically Applied to Evaluate Myocardial Ischemic Function in Patients With Stable Coronary Artery Disease
NCT06123728 ·Status: RECRUITING
-
CMR-AI and Outcomes in AS
NCT06128876 ·Status: ACTIVE_NOT_RECRUITING
-
Non-contrast Enhanced Cardiac Magnetic Resonance Normal Values and Imaging Protocols
NCT01728597 ·Status: RECRUITING
-
Cardiac Magnetic Resonance for Risk Stratification in Dilated Cardiomyopathy
NCT04990297 ·Status: RECRUITING