Breast CancerPhase 3NCT00942396
Study to Compare the Diagnostic Accuracy of Nuance Full-Field Digital Mammography to Screen-Film Mammography
A Phase 3 study testing Full Field Digital Mammogram (Planmed Sophie Nuance) in people with Breast Cancer, run by Planmed Oy at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Full Field Digital Mammogram (Planmed Sophie Nuance)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2008to Mar 2011
- Phase
- Phase 3
- 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 40 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Rose
Houston, Texas, 77034
Mroz-Baier Breast Care Clinic
Memphis, Tennessee, 38119
About this study
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.
Read the detailed description
Objectives: 1) To establish the non-inferiority of 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; and 2) To demonstrate in a comparative side-by-side feature analysis that interpretations based on the Planmed Sophie Nuance FFDM X-ray System are diagnostically non-inferior to SFM in the detection of breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Full Field Digital Mammogram (Planmed Sophie Nuance)
- Keywords
- Mammography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full Field Digital Mammogram (Planmed Sophie Nuance)Device
Also called mammography, digital mammography
Full Field Digital Mammogram
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Full Field Digital Mammogram (Planmed Sophie Nuance) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Approximately one year after completion of study.
Secondary outcomes (7)
area under the ROC curve based on the maximum POM score per subject-breast
Measured: 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;
Measured: 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;
Measured: 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;
Measured: 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.
Measured: Approximately one year after completion of study.
Feature Analysis Study; side by side assessment of SFM and FFDM images and comparison of quality features: lesion conspicuity, tissue visibility at chest wall, tissue visibility at skin line, axillary details (MLO), overall contrast, overall sharpness
Measured: Approximately one year after completion of study.
Adverse event assessment
Measured: Approximately 24 hours after completion of FFDM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2009 (estimated)
- Study startApr 2008
- Primary completionMar 2011 (estimated)
- Study completionMar 2011 (estimated)
Why it stopped: FDA changed classification of device and no longer requires this type of clinical data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Planmed Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sami Tohka, PhD, Study director, Planmed Oy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942396
- Sponsor's protocol ID
- TK01007
- Status last verified
- Jun 2011
- First submitted
- 7 Jul 2009
- Last updated
- 9 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Compare the Diagnostic Accuracy of Nuance Full-Field Digital Mammography to Screen-Film Mammography
- ClinicalTrials.gov ID
- NCT00942396
- Acronym / sponsor ID
- TK01007
- Conditions
- Breast Cancer
- Keywords
- Mammography
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: FDA changed classification of device and no longer requires this type of clinical data
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Planmed OyIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 20 Jul 2009 (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.
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.
Detailed description
Objectives: 1) To establish the non-inferiority of 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; and 2) To demonstrate in a comparative side-by-side feature analysis that interpretations based on the Planmed Sophie Nuance FFDM X-ray System are diagnostically non-inferior to SFM in the detection of breast cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mammography | Experimental | Device: Full Field Digital Mammogram (Planmed Sophie Nuance)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 |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 -
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Full Field Digital Mammogram (Planmed Sophie Nuance)Also: mammography, digital mammographyFull Field Digital Mammogram | Device | mammography |
Primary outcome
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
Time frame: Approximately one year after completion of study.
7 secondary outcomes
area under the ROC curve based on the maximum POM score per subject-breast
Time frame: 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;
Time frame: 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;
Time frame: 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;
Time frame: 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.
Time frame: Approximately one year after completion of study.
Feature Analysis Study; side by side assessment of SFM and FFDM images and comparison of quality features: lesion conspicuity, tissue visibility at chest wall, tissue visibility at skin line, axillary details (MLO), overall contrast, overall sharpness
Time frame: Approximately one year after completion of study.
Adverse event assessment
Time frame: Approximately 24 hours after completion of FFDM
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2011.
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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.
Sami Tohka, PhD study director
Planmed Oy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Full Field Digital Mammogram (Planmed Sophie Nuance) in people with Breast Cancer, run by Planmed Oy at 2 sites 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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 9 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
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 (time frame: Approximately one year after completion of study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2011.