Cardiac 3D MRI in Pediatric Cancer Patients

NCT02130934 | Withdrawn

• 1 other identifier: 14-0315
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

This is a non-randomized prospective pilot study in a single academic center with historic controls. This study will compare Cardiac Magnetic Resonance Images (MRI) of patients who have undergone childhood cancer treatment that has cardio-toxic effects to historic controls. The ultimate goal of this study is to develop a safe and effective method for early diagnosis of heart problems in children who are receiving chemotherapy treatments that may be toxic to the heart.

Conditions

Childhood Cancer

Keywords

Childhood cancer; anthracyclines; cardiotoxicity; cardiac MRI; cumulative does of at least 150 mg/m2 of anthracyclines; Ventricular function

Outcome Measures

Primary Outcomes (1)

• Ventricular Function Measurement

  Quantify ventricular functional measurements including strain patterns and measurements using offline processing software that Dr. Fornwalt lab has.

  Up to 2 years

Study Arms (1)

childhood cancer survivors

Cardiac 3D MRI

Procedure: Cardiac 3D MRI

Interventions

Cardiac 3D MRI PROCEDURE

childhood cancer survivors

Eligibility Criteria

• Age: 8 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will come from the Kentucky Children's Hospital Hematology/Oncology clinic. The study team will ask the subject's primary physician to introduce the study in clinic to any patient who is identified by the study team as meeting the enrollment criteria. If the patient and his/her family are interested in participating, a member of the study team will be notified, and will then consent / assent the patient and family for the study. Patients who wish to consider the study and potentially enroll later will be given contact information to call the study personnel if they wish to enroll later.

You may qualify if:

• Childhood cancer treatment which has been completed
• Received anthracyclines as part of childhood cancer treatment, at least 150 mg/m2 as cumulative dose
• normal left ventricular systolic and diastolic functions on echocardiogram

You may not qualify if:

• Ongoing cancer treatment
• Pregnancy
• Inability to undergo a cardiac MRI
• Abnormal ventricular systolic or diastolic function on echocardiogram

Sponsors & Collaborators

• Majd Makhoul: lead

Study Sites (2)

UK Medical Center

Lexington, Kentucky, 40536, United States

Location

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Neoplasms; Cardiotoxicity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Majd Makhoul, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor/Investigator

Study Record Dates

• First Submitted: May 1, 2014
• First Posted: May 6, 2014
• Study Start: May 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 15, 2016

Record last verified: 2016-11

Locations

US (2)