Breast CancerNCT00896649
Positron Emission Mammography and Standard Mammography in Women at High Risk of Breast Cancer
A study testing questionnaire administration, digital mammography and positron emission mammography in people with Breast Cancer, run by Boston Medical Center at 1 site in United States.
Trial summary
RATIONALE: Screening tests may help doctors find cancer cells early and plan better treatment for breast cancer. It is not yet known whether positron emission mammography is more effective than standard mammography in finding breast tumors. Read more about this study
- Who is it for?
- Ages 35 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- questionnaire administration, digital mammography and positron emission mammography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- DISEASE CHARACTERISTICS:
- Scheduled to undergo screening mammogram at one of the Boston Medical Center-affiliated primary care clinics and meets 1 of the following criteria:
- Dense breast tissue
- At high-risk for breast cancer
- PATIENT CHARACTERISTICS:
- Has 1 of the following racial or ethnic backgrounds based on the patient's country of birth or the mother and father's country of birth:
Show all 12Show fewer
- Hispanic
- Haitian Creole
- African American
- Caucasian
- PRIOR CONCURRENT THERAPY:
- None specified
Who cannot join
- No history of breast cancer, palpable breast mass, abnormal nipple discharge, or other focal complaints warranting diagnostic mammogram
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Cancer Research Center
Boston, Massachusetts, 02118
About this study
Official title: Impact of Dedicated Breast Positron Emission Mammography vs. Conventional Two-View Digital Mammography on Recall Rates and Cancer Detection as a Screening Examination in Underserved Women
RATIONALE: Screening tests may help doctors find cancer cells early and plan better treatment for breast cancer. It is not yet known whether positron emission mammography is more effective than standard mammography in finding breast tumors.
PURPOSE: This phase III trial is studying positron emission mammography to see how well it works compared with standard mammography in women undergoing screening mammogram at Boston Medical Center.
Read the detailed description
OBJECTIVES:
- To install the breast Positron Emission Mammography system and to test and ensure its compliance with all regulatory agencies including the American College of Radiology and the Food and Drug Administration.
- To measure and compare the number of call-backs for positron emission mammography (PEM) imaging and conventional mammography.
- To measure and compare patient satisfaction for both conventional mammography and positron emission mammography in terms of comfort and pain.
OUTLINE: Patients undergo a conventional two-view mammogram and positron emission mammography (PEM). Immediately following treatment, patients complete a questionnaire on their satisfaction with the standard mammogram and the positron emission mammography.
After completion of study treatment, patients are followed annually.
- Conditions
- Breast Cancer
- Being tested
- questionnaire administration, digital mammography, positron emission mammography
- Keywords
- 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.
questionnaire administrationOther
Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience.
digital mammographyProcedure or surgery
standard screening mammogram
positron emission mammographyProcedure or surgery
one-time positron emission mammography to compare recall rates with that of standard mammogram
| Study group | Role | What they receive |
|---|---|---|
| positron emission mammography | Experimental | questionnaire administration digital mammography positron emission mammography Receives: Other: questionnaire administration; Procedure: digital mammography; Procedure: positron emission mammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" Call-back in Mammography vs Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" in Positron Emission Mammography
Number of participants called back due to Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" Mammogram compared to number of patients with Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" in positron emission mammography
Breast Imaging Assessment Reporting and Data System (BI-RADS) Scale:
0 = Inconclusive for malignancy; call-back in mammography
- = normal
- = abnormal, with no malignancy
- = abnormal, likely benign
- = abnormal, likely malignant
- = malignant
Measured: immediately at completion of mammogram
Secondary outcomes (1)
Patient Satisfaction Level as Pertaining to Comfort and Pain for Each Study
Number of participants satisfied with positron emission mammography with regard to comfort and pain for each study 1-7 rating scale, Entries from 1-4 considered Satisfied. Entries 5-7 considered not Satisfied.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2012
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- PEM
- Masking
- None (open label)
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Gustavo Mercier, Boston Medical Center
- Investigators
- Gustavo Mercier, MD, PhD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896649
- Sponsor's protocol ID
- CDR0000640404
- Other IDs
- BUMC-H-27136, W81XWH-06-1-0309, 05063002, HRPO #A-13777.2
- Status last verified
- Apr 2017
- First submitted
- 9 May 2009
- Last updated
- 9 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Individual participant data is not useful.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dedicated Breast Positron Emission Mammography vs. Conventional Two-View Digital Mammography on Recall Rates and Cancer Detection as a Screening Examination in Underserved Women
- ClinicalTrials.gov ID
- NCT00896649
- Acronym / sponsor ID
- CDR0000640404
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Feb 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Posted 31 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Screening tests may help doctors find cancer cells early and plan better treatment for breast cancer. It is not yet known whether positron emission mammography is more effective than standard mammography in finding breast tumors.
PURPOSE: This phase III trial is studying positron emission mammography to see how well it works compared with standard mammography in women undergoing screening mammogram at Boston Medical Center.
Detailed description
OBJECTIVES:
- To install the breast Positron Emission Mammography system and to test and ensure its compliance with all regulatory agencies including the American College of Radiology and the Food and Drug Administration.
- To measure and compare the number of call-backs for positron emission mammography (PEM) imaging and conventional mammography.
- To measure and compare patient satisfaction for both conventional mammography and positron emission mammography in terms of comfort and pain.
OUTLINE: Patients undergo a conventional two-view mammogram and positron emission mammography (PEM). Immediately following treatment, patients complete a questionnaire on their satisfaction with the standard mammogram and the positron emission mammography.
After completion of study treatment, patients are followed annually.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- PEM
| Arm | Type | Receives |
|---|---|---|
| positron emission mammography | Experimental | Other: questionnaire administration, Procedure: digital mammography, Procedure: positron emission mammographyquestionnaire administration digital mammography positron emission mammography |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Scheduled to undergo screening mammogram at one of the Boston Medical Center-affiliated primary care clinics and meets 1 of the following criteria:
- Has 1 of the following racial or ethnic backgrounds based on the patient's country of birth or the mother and father's country of birth:
- None specified
Key exclusion criteria (1 listed)
- No history of breast cancer, palpable breast mass, abnormal nipple discharge, or other focal complaints warranting diagnostic mammogram
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 |
|---|---|---|
| questionnaire administrationQuestionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience. | Other | positron emission mammography |
| digital mammographystandard screening mammogram | Procedure or surgery | positron emission mammography |
| positron emission mammographyone-time positron emission mammography to compare recall rates with that of standard mammogram | Procedure or surgery | positron emission mammography |
Primary outcome
Frequency of Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" Call-back in Mammography vs Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" in Positron Emission Mammography
Time frame: immediately at completion of mammogram
Number of participants called back due to Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" Mammogram compared to number of patients with Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" in positron emission mammography Breast Imaging Assessment Reporting and Data System (BI-RADS) Scale: 0 = Inconclusive for malignancy; call-back in mammography 1. = normal 2. = abnormal, with no malignancy 3. = abnormal, likely benign 4. = abnormal, likely malignant 5. = malignant
1 secondary outcome
Patient Satisfaction Level as Pertaining to Comfort and Pain for Each Study
Time frame: One month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual participant data is not useful.
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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.
Gustavo Mercier, MD, PhD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaire administration, digital mammography and positron emission mammography in people with Breast Cancer, run by Boston Medical Center at 1 site 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 12 inclusion and 1 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: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Frequency of Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" Call-back in Mammography vs Breast Imaging Assessment Reporting and Data System (BI-RADS) "0" in Positron Emission Mammography (time frame: immediately at completion of mammogram). 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 May 2017.