Breast CancerNCT00267449
Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System
An observational study of Breast Cancer, run by ART Advanced Research Technologies Inc. at 6 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SoftScan Optical Breast Imaging System
- Type of treatment
- Medical device
- How many people
- 950 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Nov 2005to not given
- 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 20 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 10Show fewer
- 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.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
University of California-San Diego - Rebecca and John Moores Cancer Center
La Jolla, California, 92093
Denise Darrah, 858-657-7027
Christopher Comstock, M.D.
- Recruiting
Stanford University - Stanford Breast Imaging Center
Stanford, California, 94305
Leslie Roche, 650-724-5913, lesroche@stanford.edu.
Debra M Ikeda, M.D.
- Recruiting
Martin Memorial Health Systems, Stuart - Robert & Carol Weissman Cancer Center
Stuart, Florida, 34994
772-228-5858
James J Vopal, M.D.
Canada3 sites, 2 recruiting
- Active, not recruiting
MUHC- McGill University Health Center
Montreal, Quebec, H3A 1A1
- Recruiting
CAMIS - Central Alberta Medical Imaging Services
Red Deer, Alberta, T4N 4M1
403-343-6172 ext. 2259
Bernice Capusten, MD
- Recruiting
University Health Network (UNH) - Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
(416) 946-4501
Pavel Crystal, M.D.
About this study
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.
Read the detailed description
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
- Breast Cancer
- Being tested
- SoftScan Optical Breast Imaging System
- Keywords
- Spectroscopy, Near-Infrared, Mammography, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SoftScan Optical Breast Imaging SystemDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2005 (estimated)
- Study startNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ART Advanced Research Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joseph G Kozikowski, MD, Study director, ART Advanced Research Technologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00267449
- Sponsor's protocol ID
- SSC-311
- Status last verified
- Sep 2007
- First submitted
- 19 Dec 2005
- Last updated
- 11 Sep 2007
- Results posted
- No
Publications
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.
PubMed 16023382
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System
- ClinicalTrials.gov ID
- NCT00267449
- Acronym / sponsor ID
- SSC-311
- Conditions
- Breast Cancer
- Keywords
- Spectroscopy, Near-Infrared, Mammography, Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 950 participants (estimated)
- Lead sponsor
- ART Advanced Research Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2005
- First posted
- 21 Dec 2005 (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.
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
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.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SoftScan Optical Breast Imaging System | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2007.
- Background: PubMed 16023382Intes X. Time-domain optical mammography SoftScan: initial results. Acad Radiol. 2005 Aug;12(8):934-47. doi: 10.1016/j.acra.2005.05.006.
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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.
Joseph G Kozikowski, MD study director
ART Advanced Research Technologies Inc.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by ART Advanced Research Technologies Inc. at 6 sites in 2 countries.
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 1 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 11 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Margaret Polyzos ((514) 832-0777 ext. 267, mpolyzos@art.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00267449, which also lists 1 linked publication.
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 11 Sep 2007.