Study to Compare the Diagnostic Accuracy of Nuance Full-Field Digital Mammography to Screen-Film Mammography

NCT00942396 | Withdrawn Phase 3

• 1 other identifier: TK01007
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

Brief Summary

Evaluate the diagnostic accuracy of the Planmed Sophie Nuance Full Field Digital Mammography (FFDM) X-ray System compared to screen-film mammography (SFM) in the detection of breast cancer.

Conditions

Breast Cancer

Keywords

Mammography

Outcome Measures

Primary Outcomes (1)

• Area under ROC curve based on subjects' maximum POM scores; sensitivity based on subjects' maximum BI-RADS scores with 4 or higher as positive for cancer; and specificity based on subjects maximum BI-RADS scores with 4 or higher as positive for cancer

  Approximately one year after completion of study.

Secondary Outcomes (7)

• area under the ROC curve based on the maximum POM score per subject-breast

  Approximately one year after completion of study.

• area under the ROC curve based on the POM scores from the ten regions of a subject's breasts;

  Approximately one year after completion of study.

• sensitivity based on subjects' maximum BI-RADS scores using a cut-point of 3 or higher as positive for cancer;

  Approximately one year after completion of study.

• specificity based on subjects' maximum BI-RADS scores using a cut-point of 3 or higher as positive for cancer;

  Approximately one year after completion of study.

• Sensitivity and specificity based on the maximum BI-RADS scores per subject-breast using 4 or higher for positive; and sensitivity and specificity based on the maximum BI-RADS scores per subject-breast using 3 or higher for positive.

  Approximately one year after completion of study.

Study Arms (1)

mammography

EXPERIMENTAL

Women must be at least 40 years of age, presenting for routine breast cancer screening or presenting with one or both breasts scored 4 or 5 on the BI-RADS scale as a result of SFM either for routine breast cancer screening or for follow-up or diagnostic mammography

Device: Full Field Digital Mammogram (Planmed Sophie Nuance)

Interventions

Full Field Digital Mammogram (Planmed Sophie Nuance) DEVICE

Full Field Digital Mammogram

Also known as: mammography, digital mammography

mammography

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 40 years of age or older
• Subject is presenting for routine breasts cancer screening (Cohort I) OR Subject has one or both breasts scored 4 or 5 on the BI-RADS scale as a result of SFM either for routine breast cancer screening or for follow-up or diagnostic mammography (Cohort II)
• Subject's schedule permits the SFM and the FFDM to be performed no more than 30 days apart and with no intervention between the exams
• Subject will provide prospective, written informed consent
• Subject is considered capable of complying with study procedures including a willingness to return for a one-year follow-up exam -

You may not qualify if:

• Subject is pregnant or possibly pregnant or planning pregnancy within the next 15 months
• Subject has undergone a breast augmentation or breast implant? Has subject had any of the following breast procedures?
• Fine needle or cyst aspiration NOT Eligible if within past year Biopsy Not Eligible if within past year Lumpectomy (for breast cancer) Mastectomy (for breast cancer) Radiation therapy Breast reconstruction Breast reduction Not Eligible if within past year
• Subject has had an invasive breast procedure or operation within the past year
• Subject has significant existing breast trauma
• Subject has a history of breast cancer treated with operation or radiation
• Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data

Sponsors & Collaborators

• Planmed Oy: lead

Study Sites (2)

Mroz-Baier Breast Care Clinic

Memphis, Tennessee, 38119, United States

Location

The Rose

Houston, Texas, 77034, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Sami Tohka, PhD

  Planmed Oy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 7, 2009
• First Posted: July 20, 2009
• Study Start: April 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: June 9, 2011

Record last verified: 2011-06

Locations

US (2)