Clinical Utility of CMR for Diagnosis, Treatment Guidance and Prognostication of Cardiac Masses
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 2,000
- 主要终点
- Nature of the mass
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected or confirmed cardiac masses by imaging examinations (e.g., echocardiography, computed tomography).
- •Scheduled for or have completed cardiovascular magnetic resonance (CMR) examination.
排除标准
- •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).
研究组 & 干预措施
Neoplastic Cardiac Mass Cohort
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.
干预措施: CMR-Based Tissue Characterization + Lesion-Specific Clinical Management (Diagnostic Test)
Non-Neoplastic Cardiac Mass Cohort
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.
干预措施: CMR-Based Tissue Characterization + Lesion-Specific Clinical Management (Diagnostic Test)
Benign Cardiac Mass Cohort
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.
干预措施: CMR-Based Malignancy Differentiation + Tumor-Nature-Specific Clinical Management (Diagnostic Test)
Malignant Cardiac Mass Cohort
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.
干预措施: CMR-Based Malignancy Differentiation + Tumor-Nature-Specific Clinical Management (Diagnostic Test)
Favorable Prognosis Cohort
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.
干预措施: CMR-Based Prognostic Stratification + Outcome-Targeted Follow-Up (Diagnostic Test)
Unfavorable Prognosis Cohort
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.
干预措施: CMR-Based Prognostic Stratification + Outcome-Targeted Follow-Up (Diagnostic Test)
结局指标
主要结局
Nature of the mass
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Minjie Lu
MD, PhD
Chinese Academy of Medical Sciences, Fuwai Hospital
