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Detection of Aggressive Breast Tumors Using Tc-99m-NC100692

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Michael O'Connor, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00888589
First received: April 24, 2009
Last updated: March 14, 2013
Last verified: April 2012
History of Changes
  Purpose

The purpose of this study is to compare two types of radioactive drugs to see if they provide the same or different information about any disease that may be present in the participants breast.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Improved Sensitivity for the Detection of Aggressive Breast Tumors Using 99mTc-NC100692 and a Dual-headed Small Field of View CZT Gamma Camera.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Evidence of disease confirmed by surgery, or benign disease confirmed by biopsy [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2008
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients that are scheduled for a biopsy at the Mayo Clinic in Rochester, MN. The patients must have a suspicious lesion

Criteria

Inclusion Criteria:

  • Have a lesion on mammogram, ultrasound or breast MRI that measured < 15 mm in diameter, is considered suggestive or highly suggestive of malignancy according to the Breast Imaging Reporting and Data System Atlas criteria (BIRADS 4b, 4c or 5), and is scheduled for biopsy (needle biopsy and/or surgical biopsy).

OR

  • Have a lesion on mammogram, ultrasound or breast MRI that measured > 15 mm in diameter, is known to be malignant and is scheduled for surgery.
  • Patient age > 18 years of age.
  • Have a negative pregnancy test on the first day of the study, or must be postmenopausal or surgically sterilized.

Exclusion Criteria:

  • Patients will be excluded if they have a small lesion (< 15 mm) and have undergone prior needle biopsy of the lesion (such biopsy may effectively remove all or part of the lesion and angiogenesis associated with wound healing might confound imaging results with 99mTc-NC100692).
  • Patient's pregnancy is not negative on the first day of the study, or the patient is unable to complete the pregnancy test
  • Patient is unable to sit on a chair for 40 minutes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888589

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Michael O'Connor
GE Healthcare
Investigators
Principal Investigator: Judy Boughey, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Michael O'Connor, Prefessor of Radiologic Physics, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00888589     History of Changes
Other Study ID Numbers: 08-001022
Study First Received: April 24, 2009
Last Updated: March 14, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 19, 2013