BridgeMD
New treatment option for Adult Cancer Patients
Official title A Study of Cardiac Magnetic Resonance Imaging (CMR) for Evaluating Catheter-Associated Right Atrial Clot in People With Cancer
ClinicalTrials.gov ID: NCT07549477
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Documentation of Disease o Patients must have pathologically confirmed systemic cancer of any types and stages (solid tumors or hematologic...
- 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...
- CMASS will be further categorized by type (CNEO or CTHR) based on CMR tissue characterization: CNEO and CTHR can be differentiated based on presence...
- CTHR is defined as discrete mass(es) with avascular tissue properties (enhancement absent).
You likely can't join 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
See the full eligibility 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...
- 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...
- 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...
- 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...
- Allergies
- No history of allergic reaction to the gadolinium contrast agent or compounds of similar chemical or biologic composition
- people 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
- 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
- people will be excluded if they are unable to provide informed consent due to underlying clinical conditions and mental status.
- people will be excluded for getting CMR if they are
- people 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...
- people 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
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.