Community Hospital Identification of High CV Risk Patients During Cancer Treatment

Stopped early · Not applicable

Conditions studied: Breast Cancer

In brief

The overall of this proposal is to test in community hospitals the utility of a 10-min magnetic resonance imaging (MRI) scan protocol combined with proprietary image analysis algorithms for detecting early cardiovascular (CV) injury during receipt of chemotherapy for breast cancer (BrC) and lymphoma. This technology provides health-care delivery systems with a time-efficient method to identify those at risk of a future CV event so that prevention can be implemented to prolong survival and reduce morbidity in cancer survivors.

Key facts

Study ID

NCT02566109

Run by

Wake Forest University Health Sciences

People needed

6

Starts

2016-02-25

Expected to finish

2017-10-04

Last updated by the study team

2019-05-08

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly diagnosed Stage I-III breast cancer (including inflammatory and newly diagnosed recurrent breast cancer) or lymphoma with a > 2 year life expectancy
• Scheduled to receive chemotherapy with an Anthracycline (doxorubicin or epirubicin)
• = or > 21 years of age
• Prior cancers allowed if no evidence of disease
• ECOG 0 or 1
• Enrollment in NCI Protocol #: WF 98213. Patients must receive Fast MRI and 3D ECHO along with Baseline (98213) MRI prior to first chemotherapy treatment.

You may not qualify if…

• Patients with ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices.
• Most breast tissue expanders are not allowed. (If uncertain, inform the MRI tech to confirm eligibility status.)
• Unable to provide informed consent
• Symptomatic Claustrophobia
• Pregnant or breasting feeding. Due to unknown risks and potential harm to the unborn fetus a negative serum pregnancy test within 10 days prior to registration is required in patients with child-bearing potential. For this reason patients of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence (not having sex), oral contraceptives, intrauterine device (IUD), DeProvera, tubal ligation, or vasectomy of the partner (with confirmed negative sperm counts) in a monogamous relationship (same partner). An acceptable, although less reliable method involves the careful use of condoms and spermicidal foam or gel and/or cervical cap or sponge prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately.

Where it is running

• Wake Forest School of Medicine — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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