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


N/A
18 Years
90 Years
Open (Enrolling by invite only)
Female
Breast Cancer

Thank you

Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

30 days

Safety Issue:

No

Principal Investigator

Judy Boughey, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

08-001022

NCT ID:

NCT00888589

Start Date:

May 2008

Completion Date:

Related Keywords:

  • Breast Cancer
  • MBI
  • Molecular Breast Imaging
  • Breast
  • Breast Cancer
  • Molecular Imaging
  • Breast Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905