A Study of Cardiac Magnetic Resonance Imaging (CMR) for Evaluating Catheter-Associated Right Atrial Clot in People With Cancer

Mechanistic and Prognostic Evaluation of Central Venous Catheter-Associated Right Atrial Thrombus

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.

Study Overview

• Status: Recruiting
• Conditions: Adult Cancer Patients; Right Atrial Clot
• Intervention / Treatment: Diagnostic test: Cardiac MRI

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angel Chan, MD, PhD; Phone Number: 212-639-7217; Email: chana5@mskcc.org
• Study Contact Backup: Name: Adie Friedman, MD; Phone Number: 212-639-3402

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Memorial Sloan Kettering Basking Ridge (Consent Only)
      • Contact: Angel Chan, MD, PhD; Phone Number: 212-639-7217
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth (Consent only)
      • Contact: Angel Chan, MD, PhD; Phone Number: 212-639-7217
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen (Consent only )
      • Contact: Angel Chan, MD, PhD; Phone Number: 212-639-7217
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Suffolk- Commack (Consent Only)
      • Contact: Angel Chan, MD, PhD; Phone Number: 212-639-7217
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering Westchester (Consent only)
      • Contact: Angel Chan, MD, PhD; Phone Number: 212-639-7217
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center (All Protocol Activites)
      • Contact: Angel Chan, MD, PhD; Phone Number: 212-639-7217
    • Uniondale, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau (Consent Only)
      • Contact: Angel Chan, MD, PhD; Phone Number: 212-639-7217

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants in the RA Clot Group will have confirmed RA clots	Diagnostic test: Cardiac MRI; Cardiac MRI (CMR) for Central venous catheter-associated right atrial thrombus (RATHR) patients will be performed at baseline within 1 month of suspected RATHR diagnosis on echo/chest CT, and a follow up (3 months)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
association between Central venous catheter-associated right atrial thrombus (RATHR) with Cardiac MRI (CMR) tissue	Quantitative tissue characterization of RATHR will be employed to measure RATHR organization based on contrast infiltration, T1 variability altered T2*10 and susceptibility. These will be used to determine chronicity of thrombi as a predictor of therapeutic response to anticoagulation. Analyses will also include assessment of RATHR size, and geometry (border irregularity) at baseline and at 3-month follow up CMR using established methods to assess for the degree of resolution of RATHR.	up to 3 months

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Angel Chan, MD, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Cardiac Magnetic Resonance Imaging (CMR)
• Other Study ID Numbers: 25-289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No