Trial Information
Monitoring of Neoadjuvant Therapy in Locally-Advanced Breast Cancer
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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Objective Response
Outcome Description:
Correlate changes in each imaging modality with objective response to therapy, as defined by conventional criteria (clinical exam and conventional imaging).
Outcome Time Frame:
at baseline, at conclusion of treatment (up to 6 months)
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
D0605
NCT ID:
NCT01837563
Start Date:
September 2006
Completion Date:
Related Keywords:
- Locally Advanced Breast Cancer
- Breast Neoplasms
Name | Location |
Dartmouth-Hitchcock Medical Center |
Lebanon, New Hampshire 03756 |