Trial record 2 of 62 for:
Open Studies | mammography
Collection of FUJIFILM's 3Dimensional Mammograms (3DM)
This study is currently recruiting participants.
Verified March 2012 by Fujifilm Medical Systems USA, Inc.
Sponsor:
Fujifilm Medical Systems USA, Inc.
Information provided by (Responsible Party):
Fujifilm Medical Systems USA, Inc.
ClinicalTrials.gov Identifier:
NCT01542814
First received: February 27, 2012
Last updated: March 9, 2012
Last verified: March 2012
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Purpose
This image-acquisition study is designed to acquire the study image data and establish and document the clinical findings for each subject. The acquired data will be used to support FUJIFILM protocol FMSU2011-003B (Clinical Evaluation of FUJIFILM 3Dimensional Digital Mammography) and future regulatory submissions.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Device: 3Dimensional Mammography Device: 2D FFDM |
Phase 3 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Acquisition of Mammography Images for Clinical Evaluation of FUJIFILM 3Dimensional Mammography |
Resource links provided by NLM:
Further study details as provided by Fujifilm Medical Systems USA, Inc.:
Primary Outcome Measures:
- Acquire screening cases with and without breast cancer. [ Time Frame: 18-months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Fujifilm 3Dimensional Mammography |
Device: 2D FFDM
Standard of care screening mammogram.
|
| 2D FFDM |
Device: 3Dimensional Mammography
The FUJIFILM 3DM examination is a 4-view mammogram which includes CC and MLO views of each breast. For each view, a routine (0-degree) mammogram will be acquired followed immediately in the same compression by a second mammogram offset at 4 degrees.
Other Name: FUJIFILM 3Dimensional Mammography
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
All subjects who are appearing for a routine screening examination or have been referred for further diagnostic evaluation after a screening examination (within 45 days) or have a 4-view mammogram (within 45 days) due to clinical concerns will be eligible to participate in the study.
Criteria
Inclusion Criteria:
- Female.
- Any ethnic or racial origin.
- Must come through the study via the screening or diagnostic pathway described above.
- Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
- Meet none of the exclusion criteria.
Exclusion Criteria:
• Presence of a breast implant.
- Women with only a single breast; for example, post mastectomy patients.
- Is pregnant or believes she may be pregnant.
- A woman who has delivered and who has expressed the intention to breast-feed or is currently breast-feeding.
- A woman who has significant existing breast trauma.
- Have self-reported severe non-focal or bilateral breast pain affecting subject's ability to tolerate mammography examinations.
- A woman who has had a mammogram performed for the purpose of therapy portal planning.
- Inadequate technical quality mammography images, such as insufficient anatomical coverage or significant motion artifacts.
- Cannot, for any known reason, undergo follow-up mammography examinations (where clinically indicated) at the participating institution.
- Is an inmate (see US Code of Federal Regulations 45CFR46.306).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542814
Contacts
| Contact: Ellen M. D'Orsi, RT(M) | 404.778.3309 | elibert@emory.edu |
Locations
| United States, Arizona | |
| Scottsdale Medical Imaging, Limited (SMIL) | Recruiting |
| Scottsdale, Arizona, United States, 85258 | |
| Contact: Maya Hernandez 480-425-4191 mhernandez@esmil.com | |
| Principal Investigator: Denise Reddy, MD | |
| United States, Georgia | |
| Emory University Healthcare | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Ellen M. D'Orsi, RT(M) 404-778-3309 elibert@emory.edu | |
| Sub-Investigator: Mary Newell, MD | |
| Principal Investigator: Carl J D'Orsi, MD | |
| United States, New York | |
| Elizabeth Wende Breast Care, LLC (EWBC) | Not yet recruiting |
| Rochester, New York, United States, 14620 | |
| Contact: Renee Morgan, RT(R)(M) 585-758-7051 rmorgan@ewbc.com | |
| Principal Investigator: Stamatia Destounis, MD | |
Sponsors and Collaborators
Fujifilm Medical Systems USA, Inc.
Investigators
| Principal Investigator: | Carl J. D'Orsi, MD | Emory University Healthcare |
More Information
No publications provided
| Responsible Party: | Fujifilm Medical Systems USA, Inc. |
| ClinicalTrials.gov Identifier: | NCT01542814 History of Changes |
| Other Study ID Numbers: | FMSU2011-003A |
| Study First Received: | February 27, 2012 |
| Last Updated: | March 9, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Fujifilm Medical Systems USA, Inc.:
|
Screening Mammogram Diagnostic Mammogram Benign Malignant BI-RADS Categories |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on June 17, 2013