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

Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888589
• Other study ID #: 08-001022
• Status: Completed
• Phase: N/A
• First received: April 24, 2009
• Last updated: March 25, 2014
• Start date: May 2008
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Michael O'Connor	GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of disease confirmed by surgery, or benign disease confirmed by biopsy		30 days	No