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Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System

NCT ID: NCT00267449

Last Updated: 2007-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

950 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-11-30

Brief Summary

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The primary study endpoint -SoftScan adjunctive accuracy- will be used to test the hypothesis that the adjunctive combination of the SoftScan with x-ray mammography provides diagnostic accuracy that is significantly better than x-ray mammography alone.

Detailed Description

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Prospective, serially-recruited, blinded and unblinded, validation study to test that the adjunctive combination of the SoftScan with x-ray mammography provides diagnostic accuracy that is significantly better than x-ray mammography alone. Healthy volunteers and patients scheduled for tissue biopsy/excision of a suspicious breast lesion will be enrolled. Reader Studies will be performed in which interpreting investigators will perform blinded mammography interpretations, and reinterpretations of mammography and SoftScan interpretations. Diagnostic accuracy will be calculated using tissue histopathology as the reference standard.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Interventions

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SoftScan Optical Breast Imaging System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Women between the ages of 20 and 80 years of age, who are either healthy or who are scheduled to undergo a tissue biopsy of surgical excision of a suspicious breast lesion for histopathologic diagnosis.

Exclusion Criteria

For the Healthy Volunteers Population,

* subjects with a history of minor breast procedures involving either breast;
* subjects with a history of major breast procedures involving either breast;
* subjects with a history of significant acute breast abnormalities involving either breast; and
* subjects with a history of significant chronic breast abnormalities involving either breast; and

For Referred For Biopsy Population,

* subjects with a history of minor breast procedures involving either breast that were performed within 6 months prior to enrollment or which have not completed active healing at the time of enrollment;
* subjects with a history of major breast procedures involving either breast;
* subjects with a history of significant acute breast abnormalities involving either breast which have not completed active healing or resolution within 6 months prior to enrollment; and
* subjects with a history of significant chronic breast abnormalities involving either breast.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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ART Advanced Research Technologies Inc.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Joseph G Kozikowski, MD

Role: STUDY_DIRECTOR

ART Advanced Research Technologies Inc.

Locations

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University of California-San Diego - Rebecca and John Moores Cancer Center

La Jolla, California, United States

Site Status RECRUITING

Stanford University - Stanford Breast Imaging Center

Stanford, California, United States

Site Status RECRUITING

Martin Memorial Health Systems, Stuart - Robert & Carol Weissman Cancer Center

Stuart, Florida, United States

Site Status RECRUITING

CAMIS - Central Alberta Medical Imaging Services

Red Deer, Alberta, Canada

Site Status RECRUITING

University Health Network (UNH) - Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

MUHC- McGill University Health Center

Montreal, Quebec, Canada

Site Status ACTIVE_NOT_RECRUITING

Countries

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United States Canada

Central Contacts

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Margaret Polyzos

Role: CONTACT

[email protected]
(514) 832-0777 ext. 267

Facility Contacts

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Denise Darrah

Role: primary

858-657-7027

Leslie Roche

Role: primary

[email protected].
650-724-5913

Role: primary

772-228-5858

Role: primary

403-343-6172 ext. 2259

Role: primary

(416) 946-4501

References

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Intes X. Time-domain optical mammography SoftScan: initial results. Acad Radiol. 2005 Aug;12(8):934-47. doi: 10.1016/j.acra.2005.05.006.

Reference Type BACKGROUND
PMID: 16023382 (View on PubMed)

Other Identifiers

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SSC-311

Identifier Type: -

Identifier Source: org_study_id