Evaluate Cardiac Function Using Cardiac MRI and Dosimetric Correlation

NCT ID: NCT02348684

Last Updated: 2021-03-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-12-31

Brief Summary

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The association between radiation exposure and cardiac disease is well recognized, it is not fully understood if there exists an optimal or "safe" radiation dose-volume relationship.

Detailed Description

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Identification of "safe" dose volume constraints (DVC) for the heart from breast cancer radiotherapy would permit maximal oncologic benefit from radiation, identifying which patients require more complicated and resource consumptive radiation methods such as respiratory-gating or intensity modulated radiotherapy (IMRT) and establish patients who need targeted follow-up for their long term cardiac risk. Two recent technical developments now make it conceivable to identify the dose-volume relationship between heart dose and subsequent cardiac event risk: 1. CT based three dimensional conformal radiation delivery methods (3DCRT) where the precise radiation dose to any given heart volume is known, and 2. Cardiac MRI (CMR) that is more sensitive to prior methods of cardiac evaluation (e.g. SPECT) for detecting and measuring cardiac injury.

An MRI, subject health questionnaire, clinical and dosimetric data will be included in the analysis.

Conditions

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Node Positive Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Radiation therapy groups

Risk groups based on dosimetric radiation parameters.

Radiation therapy groups

Intervention Type RADIATION

Radiation Therapy treatment between 2000 and 2007.

Interventions

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Radiation therapy groups

Radiation Therapy treatment between 2000 and 2007.

Intervention Type RADIATION

Other Intervention Names

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Regional nodal irradiation following lumpectomy/mastectomy.

Eligibility Criteria

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Inclusion Criteria

* Women with node positive breast cancer treated with surgery, anthracycline-based or similar cardiotoxic chemotherapy, and regional nodal irradiation between 2000-2007.

Exclusion Criteria

* Women who have not received anthracycline-based or similar cardiotoxic chemotherapy, and regional nodal irradiation between 2000-2007.
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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Carmen Bergom

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carmen R Bergom, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

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Froedtert Hospital

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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Assomull RG, Prasad SK, Lyne J, Smith G, Burman ED, Khan M, Sheppard MN, Poole-Wilson PA, Pennell DJ. Cardiovascular magnetic resonance, fibrosis, and prognosis in dilated cardiomyopathy. J Am Coll Cardiol. 2006 Nov 21;48(10):1977-85. doi: 10.1016/j.jacc.2006.07.049. Epub 2006 Oct 31.

Reference Type BACKGROUND
PMID: 17112987 (View on PubMed)

Other Identifiers

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Cardiac MRI post RT Breast Ca

Identifier Type: -

Identifier Source: org_study_id

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