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

NCT07549477 | Recruiting

• 1 other identifier: 25-289
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 7

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.

Conditions

Right Atrial Clot; Adult Cancer Patients

Keywords

Cardiac Magnetic Resonance Imaging (CMR)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Participants in the RA Clot Group will have confirmed RA clots

EXPERIMENTAL

Diagnostic Test: Cardiac MRI

Interventions

Cardiac MRI DIAGNOSTIC_TEST

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)

Participants in the RA Clot Group will have confirmed RA clots

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• American Heart Association: collaborator

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Consent Only)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Consent Only)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Consent Only )

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk- Commack (Consent Only)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Consent Only)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Consent Only)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

Study Officials

• Angel Chan, MD, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angel Chan, MD, PhD

CONTACT

212-639-7217; chana5@mskcc.org

Adie Friedman, MD

CONTACT

212-639-3402

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 24, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (7)