NCT07549477 · Memorial Sloan Kettering Cancer Center
A Study of Cardiac Magnetic Resonance Imaging (CMR) for Evaluating Catheter-Associated Right Atrial Clot in People With Cancer
What this study is about
The researchers are doing this study to see how well cardiac magnetic resonance imaging (CMR) scans can be used to examine the properties of central venous catheter-associated right atrial clot (RA clot). This could help doctors decide on the best treatment options.
View original scientific description
The researchers are doing this study to see how well cardiac magnetic resonance imaging (CMR) scans can be used to examine the properties of central venous catheter-associated right atrial clot (RA clot). This could help doctors decide on the best treatment options.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Documentation of Disease o Patients must have pathologically confirmed systemic cancer of any types and stages (solid tumors or hematologic malignancies) at the time of CMR which will be used to evaluate the presence or absence of cardiac mass and additional tissue characterization for confirmation of RATHR.
- Definition of Disease \[or Measurable Disease\]
- Cardiac mass (CMASS) will be initially localized on cine-CMR, on which it is defined via established criteria as a discrete tissue prominence independent from normal anatomic structures, quantified based on size (area, cross-sectional linear dimensions)
- CMASS will be further categorized by type (CNEO or CTHR) based on CMR tissue characterization: CNEO and CTHR can be differentiated based on presence of contrast enhancement via the reference standard of LGE-CMR using established criteria previously validated by our group and others.
- CTHR is defined as discrete mass(es) with avascular tissue properties (enhancement absent).
- CTHR will be further subgrouped into RATHR after confirmation of its location and in relation to CVC.
- CNEO is defined as discrete mass(es) with vascular tissue properties (enhancement present),
- CNEO can be further sub-typed based on visually scored magnitude of enhancement (diffusely hyper-enhancing, mixed, predominantly hypo-enhancing) in accordance with established methods previously used by our group.
- Required Organ Function: o Adequate renal function defined as follows:
- Creatinine clearance (CrCL) of ≥30 mL/min by the Cockcroft-Gault formula (Note: For agents for which renal excretion is not a major route of clearance and for which renal toxicity is not an issue, the threshold for creatinine clearance should be ≥30 mL/min.): CrCl (mL/min) = \[140 - age (years)\] x weight (kg) 72 \
- creatinine (mg / dL)
- No history of allergic reaction to the gadolinium contrast agent or compounds of similar chemical or biologic composition
- Subjects in RATHR+ group must meet the following criteria:
- Adult cancer patients (stage I-IV) who are greater than 18 years of age
- Presence of indwelling central venous catheter (Mediport, PICC, Hickman, pheresis cath, etc) with a minimal duration of 7 days prior to CMR
- Presence of RATHR based on established CMR criteria (i.e. absence of enhancement on LGE-CMR)
- Patients who underwent CMR within the past 3 months for evaluation of cardiac masses are eligible if confirmed for the presence of RATHR
Exclusion criteria
- Known pre-existing CV disease which can affect hemodynamics within cardiac chambers as determined by the investigator, including
- Arrhythmia - chronic persistent atrial arrhythmias
- Cardiomyopathies including Ischemic or non-ischemic cardiomyopathy with LVEF \<53%
- Restrictive cardiomyopathy - cardiac amyloidosis, myocardial fibrosis
- Constrictive pericarditis
- Valvular heart disease with equal to or greater than moderate stenosis or regurgitation
- Cardiac neoplastic involvement
- Subjects will be excluded if they are unable to provide informed consent due to underlying clinical conditions and mental status.
- Subjects will be excluded for getting CMR if they are
- Subjects who would be normally excluded from undergoing a MRI examination as per institutional standard of care. At MSK, patients will be screened by radiology technicians using Memorial Hospital for Cancer and Allied Diseases Screening Questionnaire (Appendix 1) prior to getting cardiac MRI
- Subjects with presence of MRI incompatible metal fragments, aneurysm clip, implants or devices that would warrant avoidance of a strong magnetic field
- Contraindications to receive gadolinium contrast
- Renal dysfunction (GFR \<30 mL/min) or end stage renal disease
- Prior allergic reaction to gadolinium
- Subject who are unable to tolerate CMR due to clinical status, respiratory compromise, or severe claustrophobia
- Female participants who are pregnant or nursing
- Subjects defined as vulnerable populations, as defined by 45 CFR 46
- Participants at higher risk due to age, frailty, or the emergent nature of their condition
Where
- Basking Ridge, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- Commack, New York
- Harrison, New York
- New York, New York
- Uniondale, New York
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 24, 2026 · Source of record for eligibility and locations