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RITHM - Resonance Imaging Trial for Heart Biomarkers in Adolescent/Young (AYA) Cancer Survivors


N/A
16 Years
40 Years
Open (Enrolling)
Both
if Aortic Stiffness, Myocardial Wall Strain

Thank you

Trial Information

RITHM - Resonance Imaging Trial for Heart Biomarkers in Adolescent/Young (AYA) Cancer Survivors


Inclusion Criteria:



Childhood Cancer Survivors

- Diagnosis of cancer at age 21 or younger

- Current age 16-40 years

- 1year and ≤ 15 years from end of cancer treatment

- Received ≥ 200 mg/m2of anthracycline (Doxorubicin equivalent doses, see Appendix
VI; 200 mg/m2 of doxorubicin = epirubicin 300 mg/m2; daunorubicin 240 mg/m2;
zorubicin 400 mg/m2; mitoxantrone 50 mg/m2; idarubicin 40 mg/m2.)

- Asymptomatic (Appendix VII: absence of palpitations, dyspnea, edema or anginal
symptoms)

- No pre-existing diagnosis with regard to cardiovascular or cerebrovascular disease
status.

- BMI ≤35.0

Adolescent/young adults with no cancer history

- No prior diagnosis of cancer, diabetes, or lung disease

- Current age 16-40 years

- No history of radiation to chest or neck

- No prior history of chemotherapy

- Asymptomatic (Appendix VII : absence of palpitations, dyspnea, edema or anginal
symptoms) and without a pre-existing diagnosis with regard to cardiovascular or
cerebrovascular disease status.

- BMI ≤35.0

Newly diagnosed cancer patients

- Diagnosis of cancer at age 25 or younger

- Current age 16-25 years

- Planned receipt of anthracycline chemotherapy ≥ 200 mg/m2 of anthracycline
(Doxorubicin equivalent doses, see Appendix VII; 200 mg/m2 of doxorubicin =
epirubicin 300 mg/m2; daunorubicin 240 mg/m2; zorubicin 400 mg/m2; mitoxantrone 50
mg/m2; idarubicin 40 mg/m2.)

- Planned treatment course ≤ 15 months

- No pre-existing cardiovascular disease

- BMI ≤35.0

Exclusion Criteria:

All groups

- Subjects with implanted electronic devices, including but not limited to: pacemakers,
defibrillators, functioning neurostimulator devices, or other implanted electronic
devices

- Subjects with ferromagnetic cerebral aneurysm clips, or other
intraorbital/intracranial metal

- Claustrophobia

- Subjects who received total body irradiation or cranial irradiation

- History of acute myocardial infarction

- Significant ventricular arrhythmias (>20 PVC's/minute due to gating difficulty)

- Medical history of moderate or severe aortic stenosis, or other significant valvular
disease

- Women who are pregnant

- Those with pre-existing history (by self report in Group B and review of medical
records in addition to self-report for Groups A & C) of abnormal cardiovascular
function including: congenital heart disease, hypertension, diabetes,
hypercholesterolemia on treatment, a body mass index >35, history of asymptomatic
cardiac dysfunction (defined as an ejection fraction < 40 and/or shortening fraction
< 28) or symptomatic cardiac dysfunction (congestive heart failure), stroke, renal
dysfunction by history/medical records (serum creatinine >1.4), anemia, obstructive
or restrictive airways disease

- Asymptomatic cardiac dysfunction (defined as an ejection fraction < 40 and/or
shortening fraction < 28 on last ECHO or MUGA)

- Participants unwilling to complete the protocol (1 visit for Group A, B; 3 scan
studies for Group C)

- Participants unable to provide informed consent via a guardian or self

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

To determine if aortic stiffness or myocardial wall strain is increased in childhood cancer survivors who received anthracycline chemotherapy

Outcome Time Frame:

Day 1

Safety Issue:

No

Principal Investigator

Sharon M Castellino, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CCCWFU 99312

NCT ID:

NCT01719094

Start Date:

August 2012

Completion Date:

Related Keywords:

  • if Aortic Stiffness
  • Myocardial Wall Strain

Name

Location

Emory University School of MedicineAtlanta, Georgia  30322
Wake Forset University Health SciencesWinston-Salem, NC, North Carolina  27157