New Technique as an Additional Diagnostic Tool for Women Undergoing Neoadjuvant Therapy for Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00566085
Recruitment Status : Completed
First Posted : December 3, 2007
Last Update Posted : January 6, 2012
Information provided by (Responsible Party):
Dietlind Wahner-Roedler, Mayo Clinic

Brief Summary:
Molecular Breast Imaging is a highly promising novel methodology for breast cancer detection. Preliminary patient studies with our dual-detector system indicate that this system is capable of reliably detecting very small (5-10 mm) malignant lesions in the breast. Besides the usefulness of Molecular Breast Imaging for tumor detection, we speculate that tumor uptake and washout may be predictors to response to neoadjuvant therapy for patients with the diagnosis of breast cancer. We propose that in patients with breast cancer who undergo neoadjuvant chemotherapy or neoadjuvant hormone therapy that molecular breast imaging is an accurate test for assessing response rate to neoadjuvant therapy.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Molecular Breast Imaging Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : January 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Molecular Breast Imaging Procedure: Molecular Breast Imaging
A dual-detector cadmium-zinc-telluride gamma camera system mounted on a modified mammography gantry is used to image the breast. The injection dose of the radiopharmaceutical given to the patient is 28-32 mCi of 99m Tc-sestamibi.
Other Name: MBI

Primary Outcome Measures :
  1. 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). [ Time Frame: Up to 6 months ]

Secondary Outcome Measures :
  1. To document that post-neoadjuvant tumor size as determined by molecular breast imaging corresponds to tumor size found at time of surgery. [ Time Frame: Up to 6 months ]
  2. To characterize patterns of tumor uptake and washout and determine if they are predictors of response to neoadjuvant chemotherapy or neoadjuvant hormone therapy. [ Time Frame: Up to 6 months ]

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00566085

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Dietlind L. Wahner-Roedler, M.D. Mayo Clinic

Responsible Party: Dietlind Wahner-Roedler, Principal Investigator, Mayo Clinic Identifier: NCT00566085     History of Changes
Other Study ID Numbers: 07-002067
First Posted: December 3, 2007    Key Record Dates
Last Update Posted: January 6, 2012
Last Verified: January 2012

Keywords provided by Dietlind Wahner-Roedler, Mayo Clinic:
Breast Cancer
Neoadjuvant Therapy
Molecular Breast Imaging

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases