Breast Cancer FemaleNCT06008301
Comparing Breast Magnetic Resonance Imaging (MRI) and Contrast-enhanced Mammography (CEM)
A study testing State-Trait Anxiety Inventory (STAI) in people with Breast Cancer Female, run by Boston Medical Center.
Trial summary
The investigators will study the financial, time, and psychologic benefit of Contrast Enhanced Mammography (CEM) compared with Magnetic Resonance Imaging (MRI) for breast cancer evaluation and ultimately encourage practices and referring providers to use it more routinely in practice. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- State-Trait Anxiety Inventory (STAI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Jun 2027
- 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 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > or equal to 30 years
- Clinically eligible for CEM or breast MRI
- Newly diagnosed cancer
Who cannot join
- Pregnant as verified by patient report. Given that this test is being performed for clinical purposes, the determination of pregnancy status will be resolved via the standard clinical pathway.
About this study
Official title: Comparing Impact of Contrast-enhanced Mammography (CEM) to Breast MRI on Barriers to Breast Cancer Treatment
The investigators will study the financial, time, and psychologic benefit of Contrast Enhanced Mammography (CEM) compared with Magnetic Resonance Imaging (MRI) for breast cancer evaluation and ultimately encourage practices and referring providers to use it more routinely in practice.
Specific research objectives are to:
- determine financial costs of performing a CEM to breast MRI
- compare time costs involved with CEM to breast MRI
- compare psychologic costs involved with CEM to breast MRI.
- Conditions
- Breast Cancer Female
- Being tested
- State-Trait Anxiety Inventory (STAI)
- Keywords
- Contrast enhanced mammography (CEM), Breast MRI, Financial costs, Time costs, State-trait anxiety inventory (STAI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
State-Trait Anxiety Inventory (STAI)Other
The State-Trait Anxiety Inventory (STAI) has 20 items for assessing trait anxiety and 20 for state anxiety.
| Study group | Role | What they receive |
|---|---|---|
| Consent for the entire study | Experimental | Participants with a newly diagnosed breast cancer and recommended for enhanced imaging will be randomly assigned to either CEM or MRI and take the State-Trait Anxiety Inventory (STAI) before and after imaging. Receives: Other: State-Trait Anxiety Inventory (STAI) |
| Consent only for the STAI | Active comparator | Participants with a newly diagnosed breast cancer and recommended for enhanced imaging but who cannot or choose not to be randomly assigned to CEM or MRI but they consent to take the State-Trait Anxiety Inventory (STAI) before and after imaging. Receives: Other: State-Trait Anxiety Inventory (STAI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Institutional financial costs
True institutional costs will be calculated using time-driven activity based costing (TDABC) methodology to estimate the capacity cost rate (CCR, defined as cost per unit time in dollars per minute for personnel, equipment, and fixed equipment) and total cost (TC, defined as the sum of CCR per resource multiplied by time utilization and added to cost of consumable materials) for MRI and CEM.
Measured: 24 months
Patient financial costs
Patient costs will be determined by capturing insurance coverage and hospital-provided patient charges.
Measured: 24 months
Time from diagnosis to imaging modality (CEM or MRI)
Time will be measured in days and abstracted from medical records.
Measured: 24 months
Time from diagnosis to first treatment
Time will be measured in days and abstracted from medical records.
Measured: 24 months
Number of patient visits generated from the imaging modality
Number of patient visits generated from the imaging modality will be abstracted from medical records.
Measured: 24 months
Psychologic costs to patients
The State-Trait Anxiety Inventory (STAI) has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
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 posted23 Aug 2023
- Study startApr 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Why it stopped: The study never started as the PI left the insitution before IRB approval.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Alliance
- Responsible party
- Sponsor
- Investigators
- Jordana Phillips, MD FSBI, Principal investigator, Boston Medical Center, Dept of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008301
- Sponsor's protocol ID
- H-44009
- Status last verified
- Apr 2025
- First submitted
- 18 Aug 2023
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Impact of Contrast-enhanced Mammography (CEM) to Breast MRI on Barriers to Breast Cancer Treatment
- ClinicalTrials.gov ID
- NCT06008301
- Acronym / sponsor ID
- H-44009
- Conditions
- Breast Cancer Female
- Keywords
- Contrast enhanced mammography (CEM), Breast MRI, Financial costs, Time costs, State-trait anxiety inventory (STAI)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study never started as the PI left the insitution before IRB approval.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Breast Cancer Alliance
- Study start
- Apr 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 23 Aug 2023 (actual)
- 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 investigators will study the financial, time, and psychologic benefit of Contrast Enhanced Mammography (CEM) compared with Magnetic Resonance Imaging (MRI) for breast cancer evaluation and ultimately encourage practices and referring providers to use it more routinely in practice.
Specific research objectives are to:
- determine financial costs of performing a CEM to breast MRI
- compare time costs involved with CEM to breast MRI
- compare psychologic costs involved with CEM to breast MRI.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Consent for the entire study | Experimental | Other: State-Trait Anxiety Inventory (STAI)Participants with a newly diagnosed breast cancer and recommended for enhanced imaging will be randomly assigned to either CEM or MRI and take the State-Trait Anxiety Inventory (STAI) before and after imaging. |
| Consent only for the STAI | Active comparator | Other: State-Trait Anxiety Inventory (STAI)Participants with a newly diagnosed breast cancer and recommended for enhanced imaging but who cannot or choose not to be randomly assigned to CEM or MRI but they consent to take the State-Trait Anxiety Inventory (STAI) before and after imaging. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > or equal to 30 years
- Clinically eligible for CEM or breast MRI
- Newly diagnosed cancer
Key exclusion criteria (1 listed)
- Pregnant as verified by patient report. Given that this test is being performed for clinical purposes, the determination of pregnancy status will be resolved via the standard clinical pathway.
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 |
|---|---|---|
| State-Trait Anxiety Inventory (STAI)The State-Trait Anxiety Inventory (STAI) has 20 items for assessing trait anxiety and 20 for state anxiety. | Other | Consent for the entire study, Consent only for the STAI |
Primary outcome
Institutional financial costs
Time frame: 24 months
True institutional costs will be calculated using time-driven activity based costing (TDABC) methodology to estimate the capacity cost rate (CCR, defined as cost per unit time in dollars per minute for personnel, equipment, and fixed equipment) and total cost (TC, defined as the sum of CCR per resource multiplied by time utilization and added to cost of consumable materials) for MRI and CEM.
Patient financial costs
Time frame: 24 months
Patient costs will be determined by capturing insurance coverage and hospital-provided patient charges.
Time from diagnosis to imaging modality (CEM or MRI)
Time frame: 24 months
Time will be measured in days and abstracted from medical records.
Time from diagnosis to first treatment
Time frame: 24 months
Time will be measured in days and abstracted from medical records.
Number of patient visits generated from the imaging modality
Time frame: 24 months
Number of patient visits generated from the imaging modality will be abstracted from medical records.
Psychologic costs to patients
Time frame: 24 months
The State-Trait Anxiety Inventory (STAI) has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.
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 30 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Jordana Phillips, MD FSBI principal investigator
Boston Medical Center, Dept of Radiology
Questions about this trial
What is this clinical trial studying?
A study testing State-Trait Anxiety Inventory (STAI) in people with Breast Cancer Female, run by Boston Medical Center.
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 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: withdrawn, as of the sponsor's last update on 30 Apr 2025. 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?
Institutional financial costs (time frame: 24 months). The study lists 6 primary outcomes in all. 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 30 Apr 2025.