NCT00620087

Brief Summary

We aim to determine if Molecular Breast Imaging (a new nuclear medicine technique developed at Mayo) can identify malignant breast lesions in women who have atypical ductal hyperplasia, atypical lobular hyperplasia, or lobular carcinoma in situ.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 21, 2008

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

October 10, 2016

Status Verified

October 1, 2016

Enrollment Period

11.9 years

First QC Date

December 26, 2007

Last Update Submit

October 6, 2016

Conditions

Atypical Lobular HyperplasiaAtypical Ductal HyperplasiaLobular Carcinoma in Situ

Keywords

Atypical lobular hyperplasiaAtypical ductal hyperplasiaLobular carcinoma in situMolecular Breast Imaging

Outcome Measures

Primary Outcomes (1)

  • Correlation between molecular breast imaging findings and surgical pathology

    five years

Study Arms (2)

Diagnostic Arm

OTHER

Women with core-biopsy proven atypia, LCIS, or radial scar who have not yet undergone surgical excision were enrolled in the diagnostic arm. A molecular breast imaging study will be obtained.

Procedure: Molecular Breast Imaging

Surveillance arm

OTHER

Women with a diagnosis of ADH, ALH, or LCIS within the past 5 years were enrolled in the surveillance arm. A molecular breast imaging study was done at enrollment (Year 0) and repeated at Yer 2 and Year 4. Patients continued with routine screening mammography during this time period.

Procedure: Molecular Breast ImagingProcedure: Screening Mammography

Interventions

Molecular Breast ImagingPROCEDURE

Molecular breast Imaging is a new nuclear medicine technique for imaging the breast. It uses small filed of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.

Diagnostic ArmSurveillance arm
Screening MammographyPROCEDURE

A screening mammogram is used to look for signs of breast cancer in women who don't have any breast symptoms or problems. X-ray pictures of each breast are taken from 2 different angles.

Surveillance arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of biopsy-prove ADH, ALH, or LCIS within the past 5 years based on core needle biopsy and/or excisional biopsy and confirmed by a Mayo pathologist.
  • Recent core needle biopsy of the breast demonstrating ADH, ALH, or LCIS confirmed by Mayo pathologist.

You may not qualify if:

  • They are unable to understand and sign the consent form
  • They are pregnant or lactating
  • They are physically unable to sit upright and still for 40 minutes
  • They are younger than 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Rhodes DJ, Hruska CB, Conners AL, Tortorelli CL, Maxwell RW, Jones KN, Toledano AY, O'Connor MK. Journal club: molecular breast imaging at reduced radiation dose for supplemental screening in mammographically dense breasts. AJR Am J Roentgenol. 2015 Feb;204(2):241-51. doi: 10.2214/AJR.14.13357.

    PMID: 25615744BACKGROUND

MeSH Terms

Conditions

Carcinoma, Intraductal, NoninfiltratingBreast Carcinoma In Situ

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsCarcinoma in SituNeoplasms, Ductal, Lobular, and MedullaryBreast NeoplasmsNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Deborah J. Rhodes, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 26, 2007

First Posted

February 21, 2008

Study Start

August 1, 2003

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

October 10, 2016

Record last verified: 2016-10

Locations

US(1)