Clinical evaluation of 4D Breast Imaging for Personalized Breast Cancer Treatment

Conditions: breast cancer
Mamma carcinoma
10006291

Registration Number: NL-OMON53871

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 250

Inclusion Criteria

- Women >18 years old
- Diagnosis of breast cancer
- Treatment not yet initiated

Exclusion Criteria

- Suspected or confirmed pregnancy
- Women who are breastfeeding
- Women who have had bilateral mastectomy
- Women who cannot give informed consent
- Contra-indication for iodine contrast (i.e., contrast allergy, renal function
impairment (GFR <60ml/min/1.73m2))
- Contra-indication for irradiation (i.e., genetic mutation that predispose to
breast cancer)
- Women who are unable to remain prone on the BCT system for the required
amount of time
- Women who have physical limitations that would prohibit them from lying face
down

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part A: Detection of additional tumor foci and tumor centers in either breast.<br /><br>Part B: The prediction of final outcome at each imaging time point, and<br /><br>identification of the markers that allow for prediction of final outcome. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Part A:<br /><br>o The frequency and appropriateness of change in surgical planning.<br /><br>o The identification of imaging biomarkers that characterize tumor molecular<br /><br>profiles at the sub-tumor level.<br /><br>o Determination of local cell density and vascular access to the different<br /><br>tumor regions.<br /><br>o Comparison of the results obtained from the 4D DCE-BCT and DCE-MRI.<br /><br><br /><br>Part B:<br /><br>Direct comparison of the predictive and classification ability of 4D DCE-BCT<br /><br>and DCE-MRI for therapeutic response to NAT.</p><br>