Cardiac MassesNCT07335770
Cardiac Magnetic Resonance for Diagnosis, Treatment Guidance and Prognosis of Cardiac Masses (CMR)
An observational study of Cardiac Masses, run by Minjie Lu.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Masses
- What is being tested?
- CMR-Based Tissue Characterization + Lesion-Specific Clinical Management, CMR-Based Malignancy Differentiation + Tumor-Nature-Specific Clinical Management and CMR-Based Prognostic Stratification + Outcome-Targeted Follow-Up
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 31 Dec 2035
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with cardiac mass experienced CMR scanning
Who may be able to join
- Suspected or confirmed cardiac masses by imaging examinations (e.g., echocardiography, computed tomography).
- Scheduled for or have completed cardiovascular magnetic resonance (CMR) examination.
Who cannot join
- 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).
About this study
Official title: Clinical Utility of CMR for Diagnosis, Treatment Guidance and Prognostication of Cardiac Masses
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.
Read more
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
- Being tested
- CMR-Based Tissue Characterization + Lesion-Specific Clinical Management, CMR-Based Malignancy Differentiation + Tumor-Nature-Specific Clinical Management, CMR-Based Prognostic Stratification + Outcome-Targeted Follow-Up
- Keywords
- cardiovascular magnetic resonance, diagnosis, prognosis prediction
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMR-Based Tissue Characterization + Lesion-Specific Clinical ManagementDiagnostic 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 ManagementDiagnostic 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-UpDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: CMR-Based Tissue Characterization + Lesion-Specific Clinical Management | |
| 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. Receives: Diagnostic Test: CMR-Based Tissue Characterization + Lesion-Specific Clinical Management | |
| 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. Receives: Diagnostic Test: CMR-Based Malignancy Differentiation + Tumor-Nature-Specific Clinical Management | |
| 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. Receives: Diagnostic Test: CMR-Based Malignancy Differentiation + Tumor-Nature-Specific Clinical Management | |
| 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. Receives: Diagnostic Test: CMR-Based Prognostic Stratification + Outcome-Targeted Follow-Up | |
| 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. Receives: Diagnostic Test: CMR-Based Prognostic Stratification + Outcome-Targeted Follow-Up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nature of the mass
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.
Measured: 5 years
All Because of Death
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Jan 2008
- Primary completion30 Nov 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac MassesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Minjie Lu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Minjie Lu, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335770
- Sponsor's protocol ID
- CMR_Cardiac Mass
- Status last verified
- Jan 2026
- First submitted
- 27 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of CMR for Diagnosis, Treatment Guidance and Prognostication of Cardiac Masses
- ClinicalTrials.gov ID
- NCT07335770
- Acronym / sponsor ID
- CMR_Cardiac Mass
- Conditions
- Cardiac Masses
- Keywords
- cardiovascular magnetic resonance, diagnosis, prognosis prediction
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Minjie LuUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 30 Nov 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Neoplastic Cardiac Mass Cohort | – | Diagnostic Test: CMR-Based Tissue Characterization + Lesion-Specific Clinical ManagementPatients 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. |
| Non-Neoplastic Cardiac Mass Cohort | – | Diagnostic Test: CMR-Based Tissue Characterization + Lesion-Specific Clinical ManagementPatients 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. |
| Benign Cardiac Mass Cohort | – | Diagnostic Test: CMR-Based Malignancy Differentiation + Tumor-Nature-Specific Clinical ManagementPatients with histopathologically confirmed benign cardiac masses, including myxoma, fibroma, rhabdomyoma, lipoma, pericardial cyst, etc. All undergo complete CMR evaluation and long-term follow-up. |
| Malignant Cardiac Mass Cohort | – | Diagnostic Test: CMR-Based Malignancy Differentiation + Tumor-Nature-Specific Clinical ManagementPatients 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. |
| Favorable Prognosis Cohort | – | Diagnostic Test: CMR-Based Prognostic Stratification + Outcome-Targeted Follow-UpPatients 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. |
| Unfavorable Prognosis Cohort | – | Diagnostic Test: CMR-Based Prognostic Stratification + Outcome-Targeted Follow-UpPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with cardiac mass experienced CMR scanning
Key inclusion criteria (2 listed)
- Suspected or confirmed cardiac masses by imaging examinations (e.g., echocardiography, computed tomography).
- Scheduled for or have completed cardiovascular magnetic resonance (CMR) examination.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMR-Based Tissue Characterization + Lesion-Specific Clinical ManagementFor 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 | Neoplastic Cardiac Mass Cohort, Non-Neoplastic Cardiac Mass Cohort |
| CMR-Based Malignancy Differentiation + Tumor-Nature-Specific Clinical ManagementFor 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 | Benign Cardiac Mass Cohort, Malignant Cardiac Mass Cohort |
| CMR-Based Prognostic Stratification + Outcome-Targeted Follow-UpFor 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. | Diagnostic test | Favorable Prognosis Cohort, Unfavorable Prognosis Cohort |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Masses, run by Minjie Lu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nature of the mass (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.