NCT01433640

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2011

Typical duration for all trials

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

July 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

Enrollment Period

2.3 years

First QC Date

September 9, 2011

Last Update Submit

March 17, 2015

Conditions

Breast Cancer

Keywords

image on multi-modalitiesvisualize cancer lesionshighly suspicious lesions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Comparison of lesion conspicuity

    up to one year post study enrollment

Study Arms (3)

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 Criteria

Age25 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rose Medical Center

Denver, Colorado, 80220, United States

Location

Related Publications (9)

  • 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.

    PMID: 1701519BACKGROUND

  • 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.

    PMID: 15491962BACKGROUND

  • 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.

    PMID: 17392300BACKGROUND

  • 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.

    PMID: 18195383BACKGROUND

  • 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.

    PMID: 17236995BACKGROUND

  • 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.

    PMID: 19505964BACKGROUND

  • 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.

    PMID: 12888621BACKGROUND

  • 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.

    PMID: 12881585BACKGROUND

  • 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.

    PMID: 15973130BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • John Lewins, MD

    Rose Breast Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2011

First Posted

September 14, 2011

Study Start

July 1, 2011

Primary Completion

November 1, 2013

Study Completion

February 1, 2014

Last Updated

March 18, 2015

Record last verified: 2015-03

Locations

US(1)