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Monitoring of Neoadjuvant Therapy in Locally-Advanced Breast Cancer


N/A
18 Years
N/A
Open (Enrolling)
Female
Locally Advanced Breast Cancer

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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