Evaluate Cardiac Function Using Cardiac MRI and Dosimetric Correlation

Node Positive Breast Cancer Clinical Trial

Official title:

Pilot Study to Evaluate Cardiac Function Using Cardiac MRI and Dosimetric Correlation in Women Treated for Node Positive Breast Cancer With Three- Dimensional Conformal Radiation Therapy (3DCRT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02348684
• Other study ID #: Cardiac MRI post RT Breast Ca
• Status: Completed
• Start date: March 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2021
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Node Positive Breast Cancer

Intervention

Radiation:
• Radiation therapy groups
Radiation Therapy treatment between 2000 and 2007.

Locations

Country	Name	City	State
United States	Froedtert Hospital	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Epub 2006 Oct 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dose-volume Constraints for the Heart During Radiation Therapy for Breast Cancer.	Trial data will improve the understanding of cardiac function after radiotherapy and allow oncologists to start to define safe dose-volume constraints for the heart in women treated with regional nodal irradiation for breast cancer.	The day of the MRI
Primary	Cardiac MRI Parameters	Cardiac MRI parameters include Left Ventricular (LV) ejection fraction, LV mass (indexed), LV dimensions, extracellular volume (ECV), and late gadolinium enhancement (LGE).	day of MRI scan
Secondary	Correlate Cardiac MRI Parameters	Correlate cardiac MRI parameters with pre-treatment heart imaging and cardiac dose volume constraints as a measure of cardiac injury after partial heart irradiation in women with node positive breast cancer treated with surgery, anthracycline-based chemotherapy and regional nodal irradiation.	the day of MRI