Community Hospital Identification of High CV Risk Patients During Cancer Treatment

NCT02566109 | Terminated Results DMC FDA Device

• 2 other identifiers: IRB00032416WF-01115
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (4)

• Left Ventricular Ejection Fraction (LVEF) at Baseline, 2 Month Using Fast MRI, and 6 Months

  To compare baseline, 2-month (using Fast MRI), and 6 month measures in left ventricular (LV) ejection fraction

  Baseline, 2 months, and 6 months

• End Diastolic Volume (EDV) at Baseline, 2 Month, and 6 Months

  To compare baseline, 2-month (using Fast MRI), and 6 month measures in end Diastolic Volume (EDV)

  Baseline, 2 months, and 6 months

• End Systolic Volume (ESV) at Baseline, 2 Month, and 6 Months

  To compare baseline, 2-month (using Fast MRI), and 6 month measures in end Systolic Volume (ESV)

  Baseline, 2 months, and 6 months

• Pulse Wave Velocity (PWV) at Baseline and 6 Months

  To compare baseline and 6 month measures in pulse wave velocity (PWV)

  Baseline and 6 months

Secondary Outcomes (3)

• Left Ventricular Ejection Fraction (LVEF): Comparison of Magnetic Resonance Imaging (MRI) With Echocardiogram (ECHO) at Baseline

  Baseline

• End Diastolic Volume (EDV): Compare Magnetic Resonance Imaging (MRI) With Echocardiogram (ECHO) at Baseline

  Baseline

• End Systolic Volume (ESV): Compare Magnetic Resonance Imaging (MRI) With Echocardiogram (ECHO) at Baseline

  Baseline

Other Outcomes (1)

• Exploratory Algorithmic Modeling

  Baseline to 6 months

Study Arms (1)

Fast MRI

OTHER

All patients who agree to participate in this study will have a 10 minute fast MRI scan and Baseline and 6 month time periods. The fast MRI will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment.

Diagnostic Test: Fast MRI

Interventions

Fast MRI DIAGNOSTIC_TEST

The fast MRI is a 10 minute MRI scan that will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment.

Fast MRI

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Early termination leading to small number of subject analyzed.

Results Point of Contact

• Title: Gregory Hundley, MD
• Organization: Wake Forest University Health Sciences

ghundley@wakehealth.edu

336-716-0607

Study Officials

• Gregory Hundley, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: October 2, 2015
• Study Start: February 25, 2016
• Primary Completion: October 4, 2017
• Study Completion: October 4, 2017
• Last Updated: May 8, 2019
• Results First Posted: April 3, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)