Trial Outcomes & Findings for Evaluate Cardiac Function Using Cardiac MRI and Dosimetric Correlation (NCT NCT02348684)

Results Overview

Cardiac MRI parameters include Left Ventricular (LV) ejection fraction, LV mass (indexed), LV dimensions, extracellular volume (ECV), and late gadolinium enhancement (LGE).

Recruitment status

COMPLETED

Target enrollment

20 participants

Primary outcome timeframe

day of MRI scan

Results posted on

2021-03-03

Participant Flow

Participant milestones

Participant milestones
Measure	Radiation Therapy Groups Risk groups based on dosimetric radiation parameters and eligibility criteria. Radiation therapy groups: 3D Conformal Radiation Therapy (3DCRT) to breast/chestwall and regional lymph nodes with treatment between 2000 and 2009.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Radiation Therapy Groups n=20 Participants Risk groups based on dosimetric radiation parameters. Radiation therapy groups: Radiation Therapy treatment between 2000 and 2007.
Age, Categorical <=18 years	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=20 Participants
Age, Categorical >=65 years	6 Participants n=20 Participants
Sex: Female, Male Female	20 Participants n=20 Participants
Sex: Female, Male Male	0 Participants n=20 Participants
Region of Enrollment United States	20 participants n=20 Participants

PRIMARY outcome

Timeframe: day of MRI scan

Cardiac MRI parameters include Left Ventricular (LV) ejection fraction, LV mass (indexed), LV dimensions, extracellular volume (ECV), and late gadolinium enhancement (LGE).

Outcome measures

Outcome measures
Measure	Radiation Therapy Groups n=20 Participants Risk groups based on dosimetric radiation parameters and eligibility criteria. Radiation therapy groups: Radiation Therapy treatment between 2000 and 2009.
Cardiac MRI Parameters LGE	0 number of patients
Cardiac MRI Parameters LVEF, more than 1% outside normal range	0 number of patients
Cardiac MRI Parameters LV mass (indexed), higher than normal	0 number of patients
Cardiac MRI Parameters LV chamber dimensions, higher than normal	0 number of patients
Cardiac MRI Parameters Total Myocardial ECV, above 30%	3 number of patients

SECONDARY outcome

Timeframe: the day of MRI

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: The day of the MRI

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.

Outcome measures

Outcome data not reported

Adverse Events

Radiation Therapy Groups

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Carmen Bergom

Medical College of Wisconsin

Phone: 414-805-4365

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place