Cardiac MRI for catheter-associated right atrial clots in adults with cancer
Mechanistic and Prognostic Evaluation of Central Venous Catheter-Associated Right Atrial Thrombus
This will see if cardiac MRI (CMR) can accurately identify and describe right atrial clots that form around central venous catheters in adults with cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT07549477 on ClinicalTrials.gov |
What this trial studies
Adults with pathologically confirmed systemic cancer and a suspected right atrial mass will undergo cardiac magnetic resonance imaging using cine and late gadolinium enhancement (LGE) sequences. Discrete cardiac masses will be defined on cine-CMR and measured, and LGE tissue characterization will be used to determine contrast enhancement patterns. Masses that lack enhancement will be categorized as avascular catheter-associated thrombus, while enhancing masses will be considered neoplasm. Imaging findings will be compared with clinical data and available pathology or other imaging to confirm classification.
Who should consider this trial
Good fit: Adults with pathologically confirmed systemic cancer who have a suspected right atrial mass, particularly those with central venous catheters, are the intended participants.
Not a fit: Patients without a right atrial mass, without cancer, with contraindications to MRI (for example certain implanted devices or severe renal impairment limiting gadolinium use), or whose mass is not catheter-related are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could help doctors noninvasively distinguish catheter-related clot from tumor and choose safer, more appropriate treatments.
How similar studies have performed: Prior work using LGE-CMR has successfully differentiated thrombus from tumor in cardiac masses, though application specifically to catheter-associated right atrial clot is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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) * Allergies * 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 this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge (Consent Only) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Consent Only) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Consent Only ) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk- Commack (Consent Only) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Consent Only) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activites) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Consent Only) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Angel Chan, MD, PhD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Angel Chan, MD, PhD
- Email: chana5@mskcc.org
- Phone: 212-639-7217
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.