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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dietlind Wahner-Roedler, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00566085
First received: November 30, 2007
Last updated: January 4, 2012
Last verified: January 2012
  Purpose

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 Intervention
Breast Cancer
Procedure: Molecular Breast Imaging

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: January 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566085

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

Publications:
Responsible Party: Dietlind Wahner-Roedler, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00566085     History of Changes
Other Study ID Numbers: 07-002067
Study First Received: November 30, 2007
Last Updated: January 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
MBI
Breast Cancer
Neoadjuvant Therapy
Molecular Breast Imaging

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

ClinicalTrials.gov processed this record on September 18, 2014