NCT07549477 A Study of Cardiac Magnetic Resonance Imaging (CMR) for Evaluating Catheter-Associated Right Atrial Clot in People With Cancer
| NCT ID | NCT07549477 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Adult Cancer Patients |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-04-15 |
| Primary Completion | 2029-04 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2026-04-15 with a primary completion date of 2029-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Angel Chan, MD, PhD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT07549477 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Adult Cancer Patients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07549477 currently recruiting?
Yes, NCT07549477 is actively recruiting participants. Contact the research team at chana5@mskcc.org for enrollment information.
Where is the NCT07549477 trial being conducted?
This trial is being conducted at Basking Ridge, United States, Middletown, United States, Montvale, United States, Commack, United States and 3 additional locations.
Who is sponsoring the NCT07549477 clinical trial?
NCT07549477 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Angel Chan, MD, PhD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 150 participants.
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