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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Friends for an Earlier Breast Cancer Test
Information provided by (Responsible Party):
Carrie Hruska, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01653964
First received: July 24, 2012
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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 mCi Tc-99m sestamibi.


Condition Intervention Phase
Breast Cancer
Device: Gamma Medicak Instruments-LumaGem 3200S
Phase 2
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Evaluation of Half-Dose Molecular Breast Imaging With Wide Beam Reconstruction Processing

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Compare the diagnostic accuracy (sensitivity, specificity, PPV, NPV, LR(T+), LR(T-), diagnostic OR, AUC/concordance) of 8 mCi molecular breast imaging (MBI), 4 mCi MBI, and 4 mCi MBI with Wide Beam Reconstruction (WBR). [ Time Frame: At time of study (within 2 days after exam) and when enrollment has been reached (approximately 24 months) ] [ Designated as safety issue: No ]

    A timely clinical interpretation will be performed of the 8 mCi MBI. A new finding on MBI will be worked up according to the established standard of care.

    Following collection of all study MBIs, three study radiologists will provide a blinded interpretation of the following three acquisition settings for each patient: 8 mCi MBI, 4 mCi MBI, and 4 mCi MBI with WBR processing applied. The acquisitions will be anonymized and presented in randomized order at three separate reading sessions with 4-6 weeks between each session.



Secondary Outcome Measures:
  • Determine the agreement between an individual reader's interpretation (including background uptake, lesion descriptors, final assessment, and perceived image quality) of 8 mCi MBI, 4 mCi MBI, and 4 mCi MBI with WBR. [ Time Frame: At time of study (within 2 days after exam) and when enrollment has been reached (approximately 24 months) ] [ Designated as safety issue: No ]

    A timely clinical interpretation will be performed of the 8 mCi MBI. A new finding on MBI will be worked up according to the established standard of care.

    Following collection of all study MBIs, three study radiologists will provide a blinded interpretation of the following three acquisition settings for each patient: 8 mCi MBI, 4 mCi MBI, and 4 mCi MBI with WBR processing applied. The acquisitions will be anonymized and presented in randomized order at three separate reading sessions with 4-6 weeks between each session.



Estimated Enrollment: 82
Study Start Date: July 2012
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Molecular Breast Imaging Device: Gamma Medicak Instruments-LumaGem 3200S

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 RD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Carrie Hruska, Prinicipal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01653964     History of Changes
Other Study ID Numbers: 12-004437
Study First Received: July 24, 2012
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 20, 2014