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Completed

NCT Number: NCT01023802

The Use of Molecular Breast Imaging in the Evaluation of Tumor Response to Neoadjuvant Therapy in Women With Breast Cancer

In patients with breast cancer who undergo neoadjuvant chemotherapy or neoadjuvant hormone therapy molecular breast imaging (MBI) is an accurate test for assessing response rate to neoadjuvant therapy.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

About this study

The investigators propose to evaluate Molecular Breast Imaging in patients undergoing neoadjuvant therapy for breast cancer with the aims to document that 1) the change in uptake of 99mTc-sestamibi prior to initiation of neoadjuvant therapy, after 3-5 weeks of neoadjuvant therapy and at completion of neoadjuvant therapy prior to breast cancer surgery will be a reflection of the tumor response to neoadjuvant therapy.

  • Tumor response at 3-5 weeks of neoadjuvant therapy is predictive of tumor response at completions of neoadjuvant therapy.
  • Post-neoadjuvant tumor size as determined by MBI corresponds to size found at surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with breast cancer scheduled to undergo neoadjuvant chemotherapy therapy or neoadjuvant hormone therapy and who have undergone any breast imaging procedure, and in whom a repeat imaging procedure is planned prior to definite surgery. MRI of the breast for accurate tumor size evaluation is recommended but not necessarily required for study inclusion.
  • Are able to return for a 3-5 week follow-up MBI study and for the final MBI study at completion of the neoadjuvant therapy.
  • Patient age > 18

Exclusion criteria

  • Unable to understand or sign a consent form
  • Pregnant or lactating
  • Physically unable to sit upright and still for 40 minutes

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

The Use of Molecular Breast Imaging in the Evaluation of Tumor Response to Neoadjuvant Therapy in Women With Breast Cancer - A Pilot Study

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 2, 2009
Registry last updated
May 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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