Breast Cancer DiagnosisCEDEMNCT02608281
Evaluation of Diagnostic Accuracy of Contrast Enhanced Dual Energy Mammography Imaging in Comparison to CE-MRI
A study testing CONTRAST ENHANCED DUAL ENERGY (CEDEM) in people with Breast Cancer Diagnosis, run by Siemens Healthcare QT at 1 site in Austria.
Trial summary
Clinical study to evaluate diagnostic accuracy of low dose contrast enhanced dual energy mammography imaging (CEDEM+PRIME) in comparison with CE-MRI The primary objective of this clinical study is to assess diagnostic accuracy in breast cancer detection in Contrast Enhanced Dual Energy Mammography compared to CEMRI. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Diagnosis
- What is being tested?
- CONTRAST ENHANCED DUAL ENERGY (CEDEM)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2015to 1 Aug 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females at least 21 years of age or older
- A screening mammogram classified as BI-RADS® 0, 4 or 5 followed by a diagnostic CE-MRI and a histological verification of a given lesions either by needle biopsy or open surgery
- Signed informed consent after receiving a verbal and written explanation of the purpose and nature of this clinical study
Who cannot join
- Pregnant or possible pregnant as well as lactating women
- Have mammographic evidence of previous breast surgery, prior radiation to the breast, needle projection or pre-biopsy markings are evident on the mammogram
- Breast implants
- Patients who will undergo neo-adjuvant chemotherapy (BI-RADS 6)
- Inmates or mentally disabled patient.
- Renal insufficiency or contrast agent allergy
- Patients who participated in other clinical studies within the last 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Evaluate Diagnostic Accuracy of Low Dose Contrast Enhanced Dual Energy Mammography Imaging in Comparison to CE-MRI
Clinical study to evaluate diagnostic accuracy of low dose contrast enhanced dual energy mammography imaging (CEDEM+PRIME) in comparison with CE-MRI The primary objective of this clinical study is to assess diagnostic accuracy in breast cancer detection in Contrast Enhanced Dual Energy Mammography compared to CEMRI. Sensitivity and specificity will be compared for both modalities.
Read the detailed description
STUDY OBJECTIVES The primary objective of this clinical study is to assess the value of low-dose CEDEM in comparison with CE-MRI. The diagnostic accuracy in breast cancer detection of low dose CEDEM will be evaluated.
Investigator plans to explore the diagnostic quality of 4 standard view bilateral dual energy subtracted images compared to CE-MRI in a blinded reader study. A goal is to evaluate, whether sensitivity and specificity of low-dose CEDEM are comparable with breast MRI.
Subjects will be asked before diagnostic workup to participate in this clinical study. Approximately 80 subjects scheduled for a diagnostic CE-MRI (i.e., based on screening mammography classified as BI-RADS® 0, 4 or 5), will be eligible to participate in this study and will undergo a follow up 4 view bilateral low dose contrast enhanced mammography procedure.
Radiologically, subjects included in the study population will have even distribution of masses, clusters of microcalcifications, and architectural distortions as given by the nature of breast cancer development.
The study population will include all breast compositions. Diagnostic CE-MRI Examination If eligible, subjects with a positive or incomplete screening mammogram (BI-RADS 0, 4 or 5) will undergo a CE-MRI of the breast. MRI examinations will be performed on a 3 Tesla scanner (Tim trio, Siemens) with a dedicated 16 channel breast coil. A combination of high temporal and high spatial resolution imaging protocol will be used. All patients will be examined in the prone position and contrast agent (0.2mmol / body weight, GD-DOTA) will be administered i.v. as a bolus followed by a 20 ml saline flush.
Both exams (CEDEM and CE-MRI) will be scheduled in the second week of the menstrual cycle in premenopausal women. Each suspicious lesion will undergo needle or surgical biopsy (after completion of the CEDEM+PRIME procedure). Imaging findings will be compared with findings of histology.
Diagnostic CEDEM+PRIME If eligible, subjects with a completed MRI procedure will undergo a 4 standard view (CC, MLO) bilateral CEDEM examination. Due to use of the grid-less PRIME acquisition technology the AGD is limited and lies in the range of a standard mammogram. The high energy images will be acquired with the titanium filter. All acquired images - including the unprocessed images - will be collected. Recombined CEDEM images will be created offline. Contrast agent is injected as a bolus of 2 ml/kg body weight of non-ionic iodine contrast media with a power injector at a rate of 3.5ml/s followed by a 25ml saline flush.
The CEDEM diagnostic procedure will be performed not later than 7 days and at least 24 hours after the CE-MRI procedure.
- Conditions
- Breast Cancer Diagnosis
- Being tested
- CONTRAST ENHANCED DUAL ENERGY (CEDEM)
- Keywords
- Spectral Mammography, Dual energy, Contrast enhanced
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONTRAST ENHANCED DUAL ENERGY (CEDEM)Device
The CEDEM application requires the intravenous injection of iodide contrast agents. For each projection view (CC, MLO) a low and a high energy x-ray image will be acquired after Iodine based contrast medium administration. Patient will undergo CE MRI procedure.
| Study group | Role | What they receive |
|---|---|---|
| CEDEM | Other | diagnostic contrast enhanced Dual Energy mammograms after Iodine based contrast media administration compared to CE MRI Receives: Device: CONTRAST ENHANCED DUAL ENERGY (CEDEM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of contrast enhanced dual energy mammography for breast cancer diagnosis
Difference in accuracy of 11% comparing a 4-view contrast-enhanced dual energy imaging to CE-MRI assuming 11% discordant rate in the diagnosis
Measured: 24 months
Secondary outcomes (1)
sensitivity, specificity and the lesion-level ROC area.
The ROC area will be estimated from the BI-RADSS scores assigned by the readers to each suspicious lesion. The BI-RADS scores assigned by the readers in the interpretation of a CEDEM lesion will be used for the CEDEM+PRIME ROC area; the BI-RADS scores assigned by the readers in the interpretation of a CE-MRI case per lesion will be used for the CE-MRI ROC area. A receiver operating characteristic (ROC), or ROC curve, is a graphical plot that illustrates the performance of a binary classifier system as its discrimination threshold is varied. The curve is created by plotting the true positive rate (TPR) against the false positive rate (FPR) at various threshold settings
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startNov 2015
- Primary completion1 Aug 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer DiagnosisStudies 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siemens Healthcare QT
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical University of Vienna
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608281
- Sponsor's protocol ID
- C00215154
- Acronym
- CEDEM
- Status last verified
- Aug 2017
- First submitted
- 9 Oct 2015
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate Diagnostic Accuracy of Low Dose Contrast Enhanced Dual Energy Mammography Imaging in Comparison to CE-MRI
- ClinicalTrials.gov ID
- NCT02608281
- Acronym / sponsor ID
- CEDEM / C00215154
- Conditions
- Breast Cancer Diagnosis
- Keywords
- Spectral Mammography, Dual energy, Contrast enhanced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Siemens Healthcare QTIndustry (pharma, biotech, devices)
- Collaborators
- Medical University of Vienna
- Study start
- Nov 2015
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 18 Nov 2015 (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.
Clinical study to evaluate diagnostic accuracy of low dose contrast enhanced dual energy mammography imaging (CEDEM+PRIME) in comparison with CE-MRI The primary objective of this clinical study is to assess diagnostic accuracy in breast cancer detection in Contrast Enhanced Dual Energy Mammography compared to CEMRI. Sensitivity and specificity will be compared for both modalities.
Detailed description
STUDY OBJECTIVES The primary objective of this clinical study is to assess the value of low-dose CEDEM in comparison with CE-MRI. The diagnostic accuracy in breast cancer detection of low dose CEDEM will be evaluated.
Investigator plans to explore the diagnostic quality of 4 standard view bilateral dual energy subtracted images compared to CE-MRI in a blinded reader study. A goal is to evaluate, whether sensitivity and specificity of low-dose CEDEM are comparable with breast MRI.
Subjects will be asked before diagnostic workup to participate in this clinical study. Approximately 80 subjects scheduled for a diagnostic CE-MRI (i.e., based on screening mammography classified as BI-RADS® 0, 4 or 5), will be eligible to participate in this study and will undergo a follow up 4 view bilateral low dose contrast enhanced mammography procedure.
Radiologically, subjects included in the study population will have even distribution of masses, clusters of microcalcifications, and architectural distortions as given by the nature of breast cancer development.
The study population will include all breast compositions. Diagnostic CE-MRI Examination If eligible, subjects with a positive or incomplete screening mammogram (BI-RADS 0, 4 or 5) will undergo a CE-MRI of the breast. MRI examinations will be performed on a 3 Tesla scanner (Tim trio, Siemens) with a dedicated 16 channel breast coil. A combination of high temporal and high spatial resolution imaging protocol will be used. All patients will be examined in the prone position and contrast agent (0.2mmol / body weight, GD-DOTA) will be administered i.v. as a bolus followed by a 20 ml saline flush.
Both exams (CEDEM and CE-MRI) will be scheduled in the second week of the menstrual cycle in premenopausal women. Each suspicious lesion will undergo needle or surgical biopsy (after completion of the CEDEM+PRIME procedure). Imaging findings will be compared with findings of histology.
Diagnostic CEDEM+PRIME If eligible, subjects with a completed MRI procedure will undergo a 4 standard view (CC, MLO) bilateral CEDEM examination. Due to use of the grid-less PRIME acquisition technology the AGD is limited and lies in the range of a standard mammogram. The high energy images will be acquired with the titanium filter. All acquired images - including the unprocessed images - will be collected. Recombined CEDEM images will be created offline. Contrast agent is injected as a bolus of 2 ml/kg body weight of non-ionic iodine contrast media with a power injector at a rate of 3.5ml/s followed by a 25ml saline flush.
The CEDEM diagnostic procedure will be performed not later than 7 days and at least 24 hours after the CE-MRI procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CEDEM | Other | Device: CONTRAST ENHANCED DUAL ENERGY (CEDEM)diagnostic contrast enhanced Dual Energy mammograms after Iodine based contrast media administration compared to CE MRI |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Females at least 21 years of age or older
- A screening mammogram classified as BI-RADS® 0, 4 or 5 followed by a diagnostic CE-MRI and a histological verification of a given lesions either by needle biopsy or open surgery
- Signed informed consent after receiving a verbal and written explanation of the purpose and nature of this clinical study
Key exclusion criteria (7 listed)
- Pregnant or possible pregnant as well as lactating women
- Have mammographic evidence of previous breast surgery, prior radiation to the breast, needle projection or pre-biopsy markings are evident on the mammogram
- Breast implants
- Patients who will undergo neo-adjuvant chemotherapy (BI-RADS 6)
- Inmates or mentally disabled patient.
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 |
|---|---|---|
| CONTRAST ENHANCED DUAL ENERGY (CEDEM)The CEDEM application requires the intravenous injection of iodide contrast agents. For each projection view (CC, MLO) a low and a high energy x-ray image will be acquired after Iodine based contrast medium administration. Patient will undergo CE MRI procedure. | Device | CEDEM |
Primary outcome
Diagnostic accuracy of contrast enhanced dual energy mammography for breast cancer diagnosis
Time frame: 24 months
Difference in accuracy of 11% comparing a 4-view contrast-enhanced dual energy imaging to CE-MRI assuming 11% discordant rate in the diagnosis
1 secondary outcome
sensitivity, specificity and the lesion-level ROC area.
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CONTRAST ENHANCED DUAL ENERGY (CEDEM) in people with Breast Cancer Diagnosis, run by Siemens Healthcare QT at 1 site in Austria.
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 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: finished, as of the sponsor's last update on 11 Aug 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 Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnostic accuracy of contrast enhanced dual energy mammography for breast cancer diagnosis (time frame: 24 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 11 Aug 2017.