Monitoring of Neoadjuvant Therapy in Locally-Advanced Breast Cancer

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01837563

Enrollment

Registered

2013-04-23

Start date

2006-09-30

Completion date

2015-09-30

Last updated

2015-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Breast Cancer

Brief summary

The purpose of this study is to determine whether four new alternative imaging methods can be used to follow the response of breast cancer to the treatment patients are being given. These methods produce an image of the inside of the breast so that doctors can better decide whether breast cancer is responding to therapy. An important part of the study is to examine the same person with all methods in order to directly compare results. The four methods are: MRI Elasticity Imaging (abbreviated MRE), Electrical Impedance Spectroscopy (abbreviated EIS), Microwave Imaging and Spectroscopy (abbreviated MIS), Near Infrared Spectroscopy (abbreviated NIR). In addition to the experimental imaging methods, patients may also undergo a contrast-enhanced MRI, and/or additional mammography, which will help researchers compare the experimental methods. These additional examinations are accepted diagnostic procedures; they are not experimental. Some participants will have one or both of these additional examinations if clinically indicated.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Locally advanced breast cancer, with or without metastatic disease 2. Patient to receive systemic therapy 3. Breast size and epithelial integrity adequate to allow alternate imaging exams. 4. Patient able to provide written informed consent. 5. No serious associated psychiatric illness 6. Age ≥ 18 years old

Exclusion criteria

1. Cardiac pacemaker 2. Any implanted electronic device 3. Severe claustrophobia 4. Allergy to the MRI contrast agent gadolinium

Design outcomes

Primary

Measure	Time frame	Description
Objective Response	at baseline, at conclusion of treatment (up to 6 months)	Correlate changes in each imaging modality with objective response to therapy, as defined by conventional criteria (clinical exam and conventional imaging).

Countries

United States

Outcome results