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

Breast Cancer Clinical Trial

Official title:

Evaluation of Contrast-enhanced Mammography and Contrast-enhanced Breast Tomosynthesis: Comparison to Contrast-enhanced Breast MRI- A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01433640
• Other study ID #: 11-01
• Status: Completed
• Phase: N/A
• First received: September 9, 2011
• Last updated: March 17, 2015
• Start date: July 2011
• Est. completion date: February 2014

Study information

• Verified date: March 2015
• Source: Hologic, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
United States	Rose Medical Center	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Hologic, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. doi: 10.1259/bjr/80279516. Epub 2009 Jun 8. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1148/radiol.2463070410. Epub 2008 Jan 14. — View Citation

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. — View Citation

Weidner N. The importance of tumor angiogenesis: the evidence continues to grow. Am J Clin Pathol. 2004 Nov;122(5):675-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A PILOT study to determine Cancer lesion enhancement with CEM and CEBT is non-inferior to that of CEMRI.	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.	Fall 2012	No
Secondary	Comparison of lesion conspicuity	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.	up to one year post study enrollment	No