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Molecular Breast Imaging: Evaluation of a New Technique Using Scintimammography as an Additional Diagnostic Tool for Women Undergoing Neoadjuvant Therapy for Breast Cancer - A Pilot Study


N/A
18 Years
90 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Molecular Breast Imaging: Evaluation of a New Technique Using Scintimammography as an Additional Diagnostic Tool for Women Undergoing Neoadjuvant Therapy for Breast Cancer - A Pilot Study


Adjuvant therapy after surgery for breast cancer has provided significant benefits to
patients at risk for relapse. However, the success of therapy for each individual patient
will often take years to reveal. Preoperative (neoadjuvant) medical therapy is very potent
as an initial treatment for inoperable and large operable breast cancers. Tumor regression
can be achieved in the great majority of patients and downstaging frequently reduces the
need for mastectomy and it has become clear that pathologic complete response is a good
prognostic marker. Data from current trials suggest that survival is at least as good with
preoperative as with postoperative neoadjuvant therapies (1). With this observation
preoperative medical therapy has the advantage over post-operative neoadjuvant therapy that
it can be used as a short term surrogate marker for long-term outcome. With this
translational approach, the therapy for each patient can be more targeted and individualized
leading to higher success rates; and further, new therapies for early breast cancer can be
assessed much more quickly than is currently possible through protracted trials of
neoadjuvant therapy (2). This approach is therefore being increasingly utilized in patients
with lower stage breast cancers.


Inclusion Criteria:



- Women age 18 - 90

- Women with breast cancer scheduled to undergo neoadjuvant chemotherapy therapy or
neoadjuvant hormone therapy

- Women who have undergone any breast imaging procedure, and in whom a repeat imaging
procedure is planned prior to definite surgery

Exclusion Criteria:

- Pregnant or lactating

- Unable to understand or sign a consent form

- Physically unable to sit upright and still for 40 minutes

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To document that pre- and post-neoadjuvant therapy tumor size can be satisfactorily assessed by molecular breast imaging and corresponds to tumor size evaluation by conventional breast imaging procedures (mammogram, ultrasound, MRI).

Outcome Time Frame:

Up to 6 months

Safety Issue:

No

Principal Investigator

Dietlind L. Wahner-Roedler, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

07-002067

NCT ID:

NCT00566085

Start Date:

January 2008

Completion Date:

February 2010

Related Keywords:

  • Breast Cancer
  • MBI
  • Breast Cancer
  • Neoadjuvant Therapy
  • Molecular Breast Imaging
  • Breast Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905