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

Official title

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

Overview

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.

Interventions

• 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)

Primary outcome measures

• association between Central venous catheter-associated right atrial thrombus (RATHR) with Cardiac MRI (CMR) tissue [Time frame: up to 3 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 7 centers

• Memorial Sloan Kettering Basking Ridge (Consent Only) — Basking Ridge
• Memorial Sloan Kettering Monmouth (Consent Only) — Middletown
• Memorial Sloan Kettering Bergen (Consent Only ) — Montvale
• Memorial Sloan Kettering Suffolk- Commack (Consent Only) — Commack
• Memorial Sloan Kettering Westchester (Consent Only) — Harrison
• Memorial Sloan Kettering Cancer Center (All Protocol Activites) — New York
• Memorial Sloan Kettering Nassau (Consent Only) — Uniondale

Identifiers

NCT: NCT07549477 · 25-289

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗