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

April 16, 2026 updated by: Memorial Sloan Kettering Cancer Center

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
association between Central venous catheter-associated right atrial thrombus (RATHR) with Cardiac MRI (CMR) tissue
Time Frame: up to 3 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial Sloan Kettering Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American Heart Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Angel Chan, MD, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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