Breast NeoplasmsNCT02013726
MBI and Breast Tomosynthesis Screening Accuracies in Patients With Dense Breast Tissue
A study testing MBI Scan: The LumaGEM® and 3D Mammogram/Breast Tomosynthesis Scan: Selenia® Dimensions® in people with Breast Neoplasms, run by Gamma Medica, Inc..
Trial summary
Primary: In women with heterogeneous or dense breast tissue (mammographic types 3 and 4), MBI (Molecular Breast Imaging) will detect more breast cancers and have greater sensitivity in detecting breast cancer than breast tomosynthesis. Secondary: 1. Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- MBI Scan: The LumaGEM® and 3D Mammogram/Breast Tomosynthesis Scan: Selenia® Dimensions®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Oct 2017
- Phase
- Interventional
- 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 25 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women over 25 years of age with normal or increased risk of breast cancer.
- Women with type 3 or 4 breast density as determined by a breast imaging radiologist on a current unilateral (women with prior mastectomy) or bilateral mammography (within prior 6 weeks).
- No contraindications to breast MBI or breast tomosynthesis.
Who cannot join
- Women under the age of 25.
- Women who are or may be pregnant.
- Women who are currently lactating or have discontinued breast feeding < 2 months prior to the study.
- Male patients are excluded as subjects.
- Those unable or unwilling to provide informed consent.
About this study
Official title: Pilot Study: Dedicated Dual Head Molecular Breast Imaging Compared to Breast Tomosynthesis for Evaluation of Patients With Type 3 or 4 Mammographic Breast Density
Primary:
In women with heterogeneous or dense breast tissue (mammographic types 3 and 4), MBI (Molecular Breast Imaging) will detect more breast cancers and have greater sensitivity in detecting breast cancer than breast tomosynthesis.
Read more
Secondary:
- In women with heterogeneous or dense breast tissue, the specificity of MBI in correctly classifying subjects without breast cancer will be non-inferior to breast tomosynthesis.
- In women with heterogeneous or dense breast tissue, the area under the receiver operating characteristic (ROC) curve for MBI will be non-inferior or superior to breast tomosynthesis.
- Combining the use of MBI and breast tomosynthesis will provide performance superior to either technology alone, as manifest by a superior ROC curve area.
- Conditions
- Breast Neoplasms
- Being tested
- MBI Scan: The LumaGEM®, 3D Mammogram/Breast Tomosynthesis Scan: Selenia® Dimensions®
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBI Scan: The LumaGEM®Device
The LumaGEM Scanner is a dual-head, MBI scanner that has previously been cleared for medical marketing (510(k) number K111791), and has been used to image more than 5,000 patients to date. The LumaGEM MBI scanner is used as a diagnostic adjunct to mammography screening for problem cases The efficacy of MBI has been well documented in clinical trials. The LumaGEM MBI scanner is a dual-head, small field-of-view (FOV) device for developing an MBI image of Tc99m-Sestamibi uptake within the breast. The device consists of solid-state detectors, a data acquisition system, and a computer. The detectors are also used to immobilize the breast during image acquisition by mild compression. The detectors are housed in two heads that are positioned on both sides of a compressed breast.
3D Mammogram/Breast Tomosynthesis Scan: Selenia® Dimensions®Device
The breast tomosynthesis procedure involves x-ray imaging of the breast using a moving x-ray source and digital detectors composed of cesium iodide crystals on an amorphous silicon layer or of solely selenium in order to produce an image of the breast. This procedure is considered to basically be a modification of mammography and also is used as a diagnostic adjunct to mammography screening for problem cases.
| Study group | Role | What they receive |
|---|---|---|
| MBI Scan & Tomosynthesis Scan | Experimental | Patients will receive both scans. Receives: Device: MBI Scan: The LumaGEM®; Device: 3D Mammogram/Breast Tomosynthesis Scan: Selenia® Dimensions® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity/Cancer detection
Sensitivity being the number of scans read or labeled positive (by radiologist) divided by the total cancers confirmed by pathology results (i.e. biopsy).
Measured: 12 months
Secondary outcomes (1)
Specificity
Specificity being the total number of scans read or labeled as negative (by a radiologist) divided by number of total women without cancer. This "ground truth" of a true negative will involve in a second negative imaging scan at 12 months (follow-up exam).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startApr 2015
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gamma Medica, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013726
- Sponsor's protocol ID
- GMI_Sc-02
- Status last verified
- Aug 2014
- First submitted
- 9 Dec 2013
- Last updated
- 25 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Dedicated Dual Head Molecular Breast Imaging Compared to Breast Tomosynthesis for Evaluation of Patients With Type 3 or 4 Mammographic Breast Density
- ClinicalTrials.gov ID
- NCT02013726
- Acronym / sponsor ID
- GMI_Sc-02
- Conditions
- Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gamma Medica, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 17 Dec 2013 (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.
Primary:
In women with heterogeneous or dense breast tissue (mammographic types 3 and 4), MBI (Molecular Breast Imaging) will detect more breast cancers and have greater sensitivity in detecting breast cancer than breast tomosynthesis.
Secondary:
- In women with heterogeneous or dense breast tissue, the specificity of MBI in correctly classifying subjects without breast cancer will be non-inferior to breast tomosynthesis.
- In women with heterogeneous or dense breast tissue, the area under the receiver operating characteristic (ROC) curve for MBI will be non-inferior or superior to breast tomosynthesis.
- Combining the use of MBI and breast tomosynthesis will provide performance superior to either technology alone, as manifest by a superior ROC curve area.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MBI Scan & Tomosynthesis Scan | Experimental | Device: MBI Scan: The LumaGEM®, Device: 3D Mammogram/Breast Tomosynthesis Scan: Selenia® Dimensions®Patients will receive both scans. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women over 25 years of age with normal or increased risk of breast cancer.
- Women with type 3 or 4 breast density as determined by a breast imaging radiologist on a current unilateral (women with prior mastectomy) or bilateral mammography (within prior 6 weeks).
- No contraindications to breast MBI or breast tomosynthesis.
Key exclusion criteria (5 listed)
- Women under the age of 25.
- Women who are or may be pregnant.
- Women who are currently lactating or have discontinued breast feeding < 2 months prior to the study.
- Male patients are excluded as subjects.
- Those unable or unwilling to provide informed consent.
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 |
|---|---|---|
| MBI Scan: The LumaGEM®The LumaGEM Scanner is a dual-head, MBI scanner that has previously been cleared for medical marketing (510(k) number K111791), and has been used to image more than 5,000 patients to date. The LumaGEM MBI scanner is used as a diagnostic adjunct to mammography screening for problem cases The efficacy of MBI has been well documented in clinical trials. The LumaGEM MBI scanner is a dual-head, small field-of-view (FOV) device for developing an MBI image of Tc99m-Sestamibi uptake within the breast. The device consists of solid-state detectors, a data acquisition system, and a computer. The detectors are also used to immobilize the breast during image acquisition by mild compression. The detectors are housed in two heads that are positioned on both sides of a compressed breast. | Device | MBI Scan & Tomosynthesis Scan |
| 3D Mammogram/Breast Tomosynthesis Scan: Selenia® Dimensions®The breast tomosynthesis procedure involves x-ray imaging of the breast using a moving x-ray source and digital detectors composed of cesium iodide crystals on an amorphous silicon layer or of solely selenium in order to produce an image of the breast. This procedure is considered to basically be a modification of mammography and also is used as a diagnostic adjunct to mammography screening for problem cases. | Device | MBI Scan & Tomosynthesis Scan |
Primary outcome
Sensitivity/Cancer detection
Time frame: 12 months
Sensitivity being the number of scans read or labeled positive (by radiologist) divided by the total cancers confirmed by pathology results (i.e. biopsy).
1 secondary outcome
Specificity
Time frame: 12 months
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 25 Aug 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing MBI Scan: The LumaGEM® and 3D Mammogram/Breast Tomosynthesis Scan: Selenia® Dimensions® in people with Breast Neoplasms, run by Gamma Medica, Inc..
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 3 inclusion and 5 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 25 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Sensitivity/Cancer detection (time frame: 12 months). 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 25 Aug 2014.