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

An observational study of Breast Cancer, run by Hologic, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 25 years and older, women only
Conditions the study is for: Breast Cancer
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Jul 2011to Feb 2014
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 years and older
Women only
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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.

Show all 13Show fewer

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

Rose Medical Center
Denver, Colorado, 80220

Other trials in United States

About this study

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

Conditions: Breast Cancer
Keywords: image on multi-modalities, visualize cancer lesions, highly suspicious lesions
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01433640
Study group	Role	What they receive
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 is being measured

The primary outcome is the main question the study is designed to answer.

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:
1. 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.
Measured: Fall 2012

Secondary outcomes (1)

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.
Measured: up to one year post study enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Feb 2014

First posted14 Sep 2011 (estimated)
Study startJul 2011
Primary completionNov 2013
Study completionFeb 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01433640
Sponsor's protocol ID: 11-01
Status last verified: Mar 2015
First submitted: 9 Sep 2011
Last updated: 18 Mar 2015
Results posted: No
Data monitoring committee: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Contrast-enhanced Mammography and Contrast-enhanced Breast Tomosynthesis: Comparison to Contrast-enhanced Breast MRI- A Pilot Study
ClinicalTrials.gov ID: NCT01433640
Acronym / sponsor ID: 11-01
Conditions: Breast Cancer
Keywords: image on multi-modalities, visualize cancer lesions, highly suspicious lesions
Study type: Observational
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Hologic, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Nov 2013 (actual)
Study completion: Feb 2014 (actual)
First posted: 14 Sep 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
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.

Who may qualify

Ages: 25 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (6 listed)

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

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

A PILOT study to determine Cancer lesion enhancement with CEM and CEBT is non-inferior to that of CEMRI.
Time frame: Fall 2012
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.

1 secondary outcome

Comparison of lesion conspicuity
Time frame: up to one year post study enrollment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
Background: PubMed 1701519Weidner 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.
Background: PubMed 15491962Weidner 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.
Background: PubMed 17392300Lehman 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.
Background: PubMed 18195383Lindfors 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.
Background: PubMed 17236995Chen 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.
Background: PubMed 19505964Carton 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.
Background: PubMed 12888621Lewin 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.
Background: PubMed 12881585Jong 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.
Background: PubMed 15973130Diekmann 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.

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Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Lewins, MD principal investigator

Rose Breast Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by Hologic, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A PILOT study to determine Cancer lesion enhancement with CEM and CEBT is non-inferior to that of CEMRI. (time frame: Fall 2012). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01433640, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2015.