Use of Low-dose Molecular Breast Imaging for the Detection of Small Breast Lesions (Lowdoseprebx)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Carrie Hruska, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01285440
First received: January 26, 2011
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to show that improvements in the molecular breast imaging (MBI) technology will allow reduction of the administered dose of Tc-99m sestamibi while maintaining a sensitivity of 90% for tumor detection.


Condition Phase
Suspicious Breast Lesion for Which Biopsy is Scheduled
Phase 3

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Determination of the Sensitivity of Low-dose Molecular Breast Imaging for the Detection of Small Breast Lesions

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Effective dose needed for detection of lesion [ Time Frame: End of study when all data is collected ] [ Designated as safety issue: No ]
    The sensitivity of MBI for detection of the index lesion identified by other imaging will be determined as a function of the effective administered dose of Tc-99m sestamibi


Estimated Enrollment: 150
Study Start Date: March 2010
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Diagnostic Imaging

Detailed Description:

A total of 150 patients will be studied. Each patient will have a suspicious lesion on mammogram, ultrasound or breast magnetic resonance imaging (MRI) for which biopsy is scheduled. The lesion size on mammogram, ultrasound or breast MRI must be less than 2 cm in diameter and must be considered "suspicious" or "highly suspicious" for malignancy. Following injection of 8 mCi Tc-99m sestamibi, all patients will undergo craniocaudal (CC) and mediolateral oblique (MLO) views of each breast using a molecular breast imaging (MBI) system incorporating the latest hardware and software algorithms. Each image will be acquired for 10 minutes in dynamic mode as 4 x 2.5 minute images. Summation of a given number of frames from each acquisition will yield images of an increasing mCi dose. Hence with an 8 mCi injection and a dynamic acquisition mode, we can evaluate the sensitivity of MBI as a function of administered doses of Tc-99m sestamibi ranging from 2 to 8 mCi. The thickness of the breast will be recorded to determine its relevance to lesion detectability.

Patient Selection

The goal of this study is to enroll 150 female patients in this study. The rationale for a study number of 150 patients is given in Appendix D. Patients referred for a mammogram, ultrasound or breast MRI study at Mayo Clinic Rochester will be considered for the study if they meet the following criteria:

  • Have a lesion on mammogram, ultrasound or breast MRI that measured < 2 cm and is considered suspicious or highly suggestive of malignancy according to the Breast Imaging Reporting and Data System Atlas criteria (BI-RADS 4 or 5). (Note: while 2 cm is larger than the desired lesion size that we wish to study, this limit was recommended by our radiology colleagues as estimates of lesion size from mammography, ultrasound and MRI are not exact)
  • Are scheduled for biopsy (needle and/or surgical biopsy) of the suspicious lesion
  • Are > 18 years of age
  • Had a negative pregnancy test or must be postmenopausal or surgically sterilized

Eligible patients will be offered enrollment if the time interval between mammogram, ultrasound or MRI and scheduled biopsy allows for performance of MBI. Patients with prior needle biopsy of the lesion will be excluded from this study, as such biopsies may effectively remove all or part of the lesion. Prospective patients will be identified by the radiologist based on findings in their mammographic, ultrasound or MRI studies.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

A total of 150 patients will be studied. Each patient will have a suspicious lesion on mammogram, ultrasound or breast MRI for which biopsy is scheduled. The lesion size on mammogram, ultrasound or breast MRI must be less than 2 cm in diameter and must be considered "suspicious" or "highly suspicious" for malignancy

Criteria

Inclusion Criteria:

-

Patients referred for a mammogram, ultrasound or breast MRI study at Mayo Clinic Rochester will be considered for the study if they meet the following criteria:

  • Have a lesion on mammogram, ultrasound or breast MRI that measured < 2 cm and is considered suspicious or highly suggestive of malignancy according to the Breast Imaging Reporting and Data System Atlas criteria (BI-RADS 4 or 5). (Note: while 2 cm is larger than the desired lesion size that we wish to study, this limit was recommended by our radiology colleagues as estimates of lesion size from mammography, ultrasound and MRI are not exact)
  • Are scheduled for biopsy (needle and/or surgical biopsy) of the suspicious lesion
  • Are > 18 years of age
  • Had a negative pregnancy test or must be postmenopausal or surgically sterilized

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01285440

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Carrie B Hruska, PhD R-D Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Carrie Hruska, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01285440     History of Changes
Other Study ID Numbers: 10-000748
Study First Received: January 26, 2011
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
breast
biopsy
suspicious lesion
molecular breast imaging

ClinicalTrials.gov processed this record on April 22, 2014