Clinical trial NCT01433640: Dual-energy Contrast-enhanced (2D and 3D Mammography Versus Contrast-enhanced MRI)- A Pilot Study
Official title: Evaluation of Contrast-enhanced Mammography and Contrast-enhanced Breast Tomosynthesis: Comparison to Contrast-enhanced Breast MRI- A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: image on multi-modalities
visualize cancer lesions
highly suspicious lesions
Lead sponsor: Hologic, Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility 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).

Primary outcomes:
measure: A PILOT study to determine Cancer lesion enhancement with CEM and CEBT is non-inferior to that of CEMRI.
timeFrame: Fall 2012
Secondary outcomes:
measure: Comparison of lesion conspicuity
timeFrame: up to one year post study enrollment
Other outcomes:
Locations:
city: Denver
country: United States
facility: Rose Medical Center
state: Colorado
Study officials:
affiliation: Rose Breast Center
name: John Lewins, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1056/NEJM199101033240101.
citation: Weidner N. The importance of tumor angiogenesis: the evidence continues to grow. Am J Clin Pathol. 2004 Nov;122(5):675-7. doi: 10.1309/KY6E-H0LG-Y6D6-PGP5. No abstract available.
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. doi: 10.1056/NEJMoa065447. Epub 2007 Mar 28.
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.
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. doi: 10.1016/j.acra.2006.10.022.
citation: 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.
citation: Lewin JM, Isaacs PK, Vance V, Larke FJ. Dual-energy contrast-enhanced digital subtraction mammography: feasibility. Radiology. 2003 Oct;229(1):261-8. doi: 10.1148/radiol.2291021276. Epub 2003 Jul 29.
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. doi: 10.1148/radiol.2283020961. Epub 2003 Jul 24.
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. doi: 10.1097/01.rli.0000167421.83203.4e.