CompletedNCT01433640Updated Mar 18, 2015

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

An observational study in Breast Cancer, sponsored by Hologic, Inc.. Completed at 1 site in United States. Open to female participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2015-03-18.

Sponsored by Hologic, Inc. · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 30
Ages: 25 Years and older
Sex: Female

Study 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.

Conditions studied

Breast Cancer

Keywords

image on multi-modalities
visualize cancer lesions
highly suspicious lesions

In context

Lead sponsor

Hologic, Inc. is the lead sponsor of 28 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 25 Years and older
Sexes eligible: 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.

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

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
Enrollment: 30 participants (actual)

Groups and 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.

What researchers measure

Primary outcomes

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.
Time frame: Fall 2012

Secondary outcomes

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.
Time frame: up to one year post study enrollment

Study locations

1 site

Rose Medical Center
Denver, Colorado 80220, United States

References and documents

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. doi: 10.1056/NEJM199101033240101. PubMed 1701519 ↗
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. PubMed 15491962 ↗
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. PubMed 17392300 ↗
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. PubMed 18195383 ↗
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. PubMed 17236995 ↗
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. PubMed 19505964 ↗
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. PubMed 12888621 ↗
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. PubMed 12881585 ↗
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. PubMed 15973130 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01433640
Lead sponsor: Hologic, Inc.
Responsible party: Sponsor
First posted: Sep 14, 2011
Start date: Jul 2011
Primary completion: Nov 2013
Completion: Feb 2014
Last update: Mar 18, 2015

Study contacts

John Lewins, MD

principal investigator · Rose Breast Center

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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