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

March 25, 2014 updated by: Michael O'Connor

Improved Sensitivity for the Detection of Aggressive Breast Tumors Using 99mTc-NC100692 and a Dual-headed Small Field of View CZT Gamma Camera.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evidence of disease confirmed by surgery, or benign disease confirmed by biopsy
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael O'Connor

Collaborators

GE Healthcare

Investigators

  • Principal Investigator: Judy Boughey, M.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

April 24, 2009

First Submitted That Met QC Criteria

April 24, 2009

First Posted (Estimate)

April 27, 2009

Study Record Updates

Last Update Posted (Estimate)

March 27, 2014

Last Update Submitted That Met QC Criteria

March 25, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-001022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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