Skip to main content
OpenTrials
Completed

NCT Number: NCT00888589

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Evidence of disease confirmed by surgery, or benign disease confirmed by biopsy

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Michael O'Connor

Other

Collaborators

  • GE Healthcare

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Apr 27, 2009
Registry last updated
Mar 27, 2014

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.