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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants in the RA Clot Group will have confirmed RA clots | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| 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 |
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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]
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:
Exclusion Criteria:
Known pre-existing CV disease which can affect hemodynamics within cardiac chambers as determined by the investigator, including
Restrictive cardiomyopathy - cardiac amyloidosis, myocardial fibrosis
Constrictive pericarditis
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angel Chan, MD, PhD | Contact | 212-639-7217 | chana5@mskcc.org | |
| Adie Friedman, MD | Contact | 212-639-3402 |
| Name | Affiliation | Role |
|---|---|---|
| Angel Chan, MD, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Consent Only) | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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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
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| Memorial Sloan Kettering Monmouth (Consent Only) | Recruiting | Middletown | New Jersey | 07748 | United States |
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| Memorial Sloan Kettering Bergen (Consent Only ) | Recruiting | Montvale | New Jersey | 07645 | United States |
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| Memorial Sloan Kettering Suffolk- Commack (Consent Only) | Recruiting | Commack | New York | 11725 | United States |
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| Memorial Sloan Kettering Westchester (Consent Only) | Recruiting | Harrison | New York | 10604 | United States |
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| Memorial Sloan Kettering Cancer Center (All Protocol Activites) | Recruiting | New York | New York | 10065 | United States |
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| Memorial Sloan Kettering Nassau (Consent Only) | Recruiting | Uniondale | New York | 11553 | United States |
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