Dual-energy Contrast-enhanced (2D and 3D Mammography Versus Contrast-enhanced MRI)- A Pilot Study - Full Text View

Purpose

This is a pilot study to evaluate 2D contrast-enhanced mammography image and 3D (tomosynthesis) contrast-enhanced images to contrast enhanced MRI in women with greater than 95% probability of breast cancer (BIRADS 5) or confirmed breast cancer (BIRADS 6).This study will then be used to design additional studies.

Condition
Breast Cancer

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Evaluation of Contrast-enhanced Mammography and Contrast-enhanced Breast Tomosynthesis: Comparison to Contrast-enhanced Breast MRI- A Pilot Study

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Mammography

U.S. FDA Resources

Further study details as provided by Hologic, Inc.:

Primary Outcome Measures:

A PILOT study to determine Cancer lesion enhancement with CEM and CEBT is non-inferior to that of CEMRI. [ Time Frame: Fall 2012 ] [ Designated as safety issue: No ]
This Pilot study is designed to evaluate two x-ray contrast methods with contrast enhanced MRI. Each subject will be imaged with CEM, CEBT and CEMRI. The goals for this will be to:

i) Using a Likert scale, Compare the enhancement of breast cancer lesions with CEM, CEBT and CEMRI.

ii) Using a Likert scale, Compare the enhancement of benign breast lesions with CEM, CEBT and CEMRI.

The results of this study will be used to design studies to measure the sensitivity and specificity of CEM and CEBT.

Secondary Outcome Measures:

Comparison of lesion conspicuity [ Time Frame: up to one year post study enrollment ] [ Designated as safety issue: No ]
Using a Likert scale the CEM and the CBT images will be compared with standard pre-contrast mammography and tomosynthesis images to determine lesion conspicuity.

Estimated Enrollment:	70
Study Start Date:	July 2011
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
Contrast-enhanced Mammography Subjects will undergo 2D imaging with iodine contrast.
Contrast-enhanced Breast Tomosynthesis Subjects will undergo 3D imaging with iodine contrast.
Contrast-enhanced MRI Each subject imaged with iodine contrast will also be imaged with contrast-enhanced MRI using gadolinium.

Eligibility

Ages Eligible for Study:	25 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The study population includes females of any race and ethnicity. The subjects must ba at least 25 years old and has a lesion of BIRADS 5 or BIRADS 6 as determined by a radiologist.

Criteria

Inclusion Criteria:

Subject is a female of any race and ethnicity.
Subject is at least 25 years old
Subject has or will have a contrast enhanced breast MRI +/- 31 days of enrollment with no interval treatment or procedure between the two studies
Subject has BIRADS 6 or BIRADS 5 cancer or as determined by the radiologist
>50% of the biopsied cancer mass must remain following biopsy OR
A calcification must be at least 2cm in maximum dimension prior to biopsy or at least 1cm in maximum dimension following biopsy

Exclusion Criteria:

Subject is unable or unwilling to undergo informed consent
Subject has breast implant in the breast to be imaged
Subject is pregnant
Subject is breast feeding or lactating
Subject has a known allergy to gadolinium contrast agents.
Subject has a contraindication for MRI.
Subject suspected to be at risk to complication from the contrast agents.
Subject has a documented renal insufficiency,
Subject requires renal dialysis.
Subject has had a prior reaction to iodinated contrast.
Subject has had a prior episode of anaphylactic reaction to any substance.
Subject has taken metformin (Glucophage) within 48 hours of study procedures.
Subject has multiple allergies and/or severe asthma regularly treated with medication (prescription and/or over-the-counter).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433640

Locations

United States, Colorado
Rose Medical Center	Recruiting
Denver, Colorado, United States, 80220
Contact: John Lewin, MD 720-333-1479 jlewin@divrad.com
Principal Investigator: John Lewin, MD

Sponsors and Collaborators

Hologic, Inc.

Investigators

Principal Investigator:	John Lewins, MD	Rose Breast Center
Principal Investigator:	Phoebe Freer, MD	Massachusetts General Hospital

More Information

Publications:

Weidner N, Semple JP, Welch WR, Folkman J. Tumor angiogenesis and metastasis--correlation in invasive breast carcinoma. N Engl J Med. 1991 Jan 3;324(1):1-8.

Weidner N. The importance of tumor angiogenesis: the evidence continues to grow. Am J Clin Pathol. 2004 Nov;122(5):675-7. No abstract available.

Lehman CD, Gatsonis C, Kuhl CK, Hendrick RE, Pisano ED, Hanna L, Peacock S, Smazal SF, Maki DD, Julian TB, DePeri ER, Bluemke DA, Schnall MD; ACRIN Trial 6667 Investigators Group. MRI evaluation of the contralateral breast in women with recently diagnosed breast cancer. N Engl J Med. 2007 Mar 29;356(13):1295-303. Epub 2007 Mar 28.

Lindfors KK, Boone JM, Nelson TR, Yang K, Kwan AL, Miller DF. Dedicated breast CT: initial clinical experience. Radiology. 2008 Mar;246(3):725-33. Epub 2008 Jan 14.

Chen SC, Carton AK, Albert M, Conant EF, Schnall MD, Maidment AD. Initial clinical experience with contrast-enhanced digital breast tomosynthesis. Acad Radiol. 2007 Feb;14(2):229-38.

Carton AK, Gavenonis SC, Currivan JA, Conant EF, Schnall MD, Maidment AD. Dual-energy contrast-enhanced digital breast tomosynthesis--a feasibility study. Br J Radiol. 2010 Apr;83(988):344-50. Epub 2009 Jun 8.

Lewin JM, Isaacs PK, Vance V, Larke FJ. Dual-energy contrast-enhanced digital subtraction mammography: feasibility. Radiology. 2003 Oct;229(1):261-8. Epub 2003 Jul 29.

Jong RA, Yaffe MJ, Skarpathiotakis M, Shumak RS, Danjoux NM, Gunesekara A, Plewes DB. Contrast-enhanced digital mammography: initial clinical experience. Radiology. 2003 Sep;228(3):842-50. Epub 2003 Jul 24.

Diekmann F, Diekmann S, Jeunehomme F, Muller S, Hamm B, Bick U. Digital mammography using iodine-based contrast media: initial clinical experience with dynamic contrast medium enhancement. Invest Radiol. 2005 Jul;40(7):397-404.

Responsible Party:	Hologic, Inc.
ClinicalTrials.gov Identifier:	NCT01433640 History of Changes
Other Study ID Numbers:	11-01
Study First Received:	September 9, 2011
Last Updated:	November 30, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Hologic, Inc.:

image on multi-modalities
visualize cancer lesions
highly suspicious lesions

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013