Clinical trial · Interventional
Community Hospital Identification of High CV Risk Patients During Cancer Treatment
Community Hospital Identification of High CV Risk Patients During Cancer Treatment (CHI)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding Issues
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fast MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Fast MRI
- description
- 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.
- interventionNames
- Diagnostic Test: Fast MRI
Primary outcomes (4)
- measure
- Left Ventricular Ejection Fraction (LVEF) at Baseline, 2 Month Using Fast MRI, and 6 Months
- timeFrame
- Baseline, 2 months, and 6 months
- description
- To compare baseline, 2-month (using Fast MRI), and 6 month measures in left ventricular (LV) ejection fraction
- measure
- End Diastolic Volume (EDV) at Baseline, 2 Month, and 6 Months
- timeFrame
- Baseline, 2 months, and 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available