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

Официальное название

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

Обзор

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.

Вмешательства

• Диагностический тест 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-
• Диагностический тест 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 s
• Диагностический тест 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/unfa

Первичные конечные точки

• Nature of the mass [Срок оценки: 5 years]
• All Because of Death [Срок оценки: 5 years]

Критерии участия

Критерии включения

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

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07335770 · CMR_Cardiac Mass

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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