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Evaluation of Half-Dose Molecular Breast Imaging With Wide Beam Reconstruction Processing (Split-Dose)

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ClinicalTrials.gov Identifier: NCT01653964
Recruitment Status : Completed
First Posted : July 31, 2012
Results First Posted : September 18, 2017
Last Update Posted : September 18, 2017
Sponsor:
Collaborator:
Friends for an Earlier Breast Cancer Test
Information provided by (Responsible Party):
Carrie Hruska, Mayo Clinic

Brief Summary:
The primary objective of this work is to determine if half-dose Molecular Breast Imaging (MBI) performed with 4 mCi Tc-99m sestamibi with or without Wide Beam Reconstruction applied can achieve image quality and diagnostic accuracy non-inferior to that of standard MBI performed with 8 millicurie (mCi) Tc-99m sestamibi.

Condition or disease Intervention/treatment Phase
Breast Cancer Diagnostic Test: Molecular breast imaging Not Applicable

Detailed Description:
Recent implementation of dose reduction strategies for Molecular Breast Imaging now allow performance of MBI at an administered dose of 8 mCi Tc-99m sestamibi, which is reduced from the previously used doses of 20-30 mCi. In order to safely introduce MBI as a screening modality, we aim to perform MBI using 4 mCi Tc-99m sestamibi. An image processing algorithm called Wide Beam Reconstruction (WBR) has been tailored for MBI technology with the goal of allowing either the current administered dose or current acquisition time to be reduced by half.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Half-Dose Molecular Breast Imaging With Wide Beam Reconstruction Processing
Study Start Date : July 2012
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Molecular breast imaging
Molecular Breast Imaging at 4 mCi dose and at 8 mCi dose, consecutively.
Diagnostic Test: Molecular breast imaging
Molecular breast imaging performed with injection of Tc-99m sestamibi and a dedicated gamma camera (Luma Gem, Gamma Medica)



Primary Outcome Measures :
  1. Compare the Diagnostic Accuracy of 8 mCi Molecular Breast Imaging (MBI) With 4 mCi MBI. [ Time Frame: At time of study (within 2 days after exam) and when enrollment has been reached (approximately 24 months) ]


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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subgroup 1, Patients with breast lesions:

-At least one breast lesion detected by mammogram, ultrasound or breast MRI that measures < 20 mm in greatest dimension, presents as a mass, is considered suspicious or highly suggestive of malignancy according to the Breast Imaging Reporting and Data System Atlas criteria (BIRADS 4 or 5), and is scheduled for core-needle biopsy or surgical biopsy.

OR

-At least one breast lesion that measures between > 10 mm but < 20 mm in greatest dimension, presents as a mass, is biopsy-proven as malignant, and is scheduled for surgical resection.

AND

  • Age > 40 years
  • Negative pregnancy test, postmenopausal, or surgically sterilized

Subgroup 2, Patients without known breast lesions:

  • Negative screening mammogram performed at Mayo Clinic Rochester within 15 months prior to performance of study MBI
  • No signs or symptoms of breast disease
  • Age > 40 years
  • Negative pregnancy test, postmenopausal, or surgically sterilized

Exclusion Criteria:

  • Vacuum-assisted or excisional biopsy has been performed prior to the study MBI. Reason: these types of biopsies are more likely to remove all of the tumor
  • MBI is performed after biopsy and neo-adjuvant chemotherapy is planned prior to surgery. Reason: true tumor size will not be able to be ascertained from the final pathology findings
  • Breast implants. Reason: cases with breast implants will be easily identifiable on blinded interpretation to take place at the study end
  • Suspected that breasts will not fit in the MBI field of view. Reason: cases that require tiled views or additional views will be easily identifiable on blinded interpretation to take place at the study end
  • Only one breast remaining. Reason: unilateral cases will be easily identifiable on blinded interpretation to take place at the study end; injection timing is designed for bilateral views
  • Pregnancy test (if necessary) is not negative, or the patient is unable to complete the pregnancy test
  • Physically unable to sit upright and still remain still during two consecutive MBI studies over the course of a 2-hour period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01653964


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Friends for an Earlier Breast Cancer Test
Investigators
Principal Investigator: Carrie B Hruska, PhD Mayo Clinic

Additional Information:
Responsible Party: Carrie Hruska, Prinicipal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01653964     History of Changes
Other Study ID Numbers: 12-004437
First Posted: July 31, 2012    Key Record Dates
Results First Posted: September 18, 2017
Last Update Posted: September 18, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Carrie Hruska, Mayo Clinic:
suspicious
lesion
breast
cancer
screening
mammogram
negative