Breast CancerPSIDNCT07277738
Precision Supplemental Imaging in Women With Dense Breasts
A study testing Prognosia Breast, Mammogram and MRI in people with Breast Cancer and Cancer of the Breast, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Recent research has shown that, among women with extremely dense breasts and normal results on mammogram, magnetic resonance imaging (MRI) use has significantly reduced the occurrence of breast cancer that is diagnosed during the time between two regular screening mammograms (also known as interval cancers). Read more about this study
- Who is it for?
- Ages 25 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Cancer of the Breast
- What is being tested?
- Prognosia Breast, Mammogram and MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2026to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal screening mammogram within 90 days prior to enrollment. Bi-Rads of 1 or 2.
- Dense breasts, either:
- Class C density ("the breasts are heterogeneously dense, which may obscure small masses")
- Class D density ("the breasts are extremely dense, which lowers the sensitivity of mammography")
- Assigned female at birth.
- Between 40 to 74 years of age (inclusive).
- Ability to understand and willingness to sign an IRB approved written informed consent document.
Who cannot join
- Screening mammogram with BI-Rads of 0.
- Contraindication to MRI with contrast (e.g. claustrophobia, metal objects in the body, known sensitivity/allergy to gadolinium).
- Prior or concurrent malignancy whose natural history has the potential to interfere with the study intervention (breast cancer or non-classic LCIS). Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.
- Prior MRI screening of the breast.
- Known to be BRCA 1/2 positive or presence of any other known high penetrance genetic marker.
- Is receiving any endocrine therapy.
- Has breast implants.
- Is breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Tabassum Ahmad, M.D., 314-474-7696, ahmad.tabassum@wustl.edu
Tabassum Ahmad, M.D.
About this study
Official title: Precision Supplemental Imaging in Women With Dense Breasts (PSID Trial)
Recent research has shown that, among women with extremely dense breasts and normal results on mammogram, magnetic resonance imaging (MRI) use has significantly reduced the occurrence of breast cancer that is diagnosed during the time between two regular screening mammograms (also known as interval cancers).
The investigators have developed and validated an approach to use the whole mammogram image, develop a mammogram risk score (MRS), and calibrate this to the SEER breast cancer incidence rates for US women. This model (Prognosia Breast) generates an absolute 5-year risk of breast cancer and classifies approximately 5.7% of the population as high risk using the ASCO 3% cut point as used for endocrine therapy to reduce risk. Follow-up generates an incidence of 25.2 cases per 1,000 women per year.
- Conditions
- Breast Cancer, Cancer of the Breast
- Being tested
- Prognosia Breast, Mammogram, MRI
- Keywords
- Dense breasts, Abbreviated MRI, Risk assessment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prognosia BreastDevice
Also called MRS, Mammogram absolute risk score
The risk output from this algorithm is calibrated to US Surveillance, Epidemiology, and End Results (SEER) 5-year risk and so estimates for each woman the personal 5-year risk.
MammogramDevice
Standard of care annual screening mammogram
MRIDevice
Also called Magnetic resonance imaging
MRI at the time of annual screening mammogram
| Study group | Role | What they receive |
|---|---|---|
| Feasibility: Recommended MRI | Experimental | Consenting and eligible participants will be recommended to undergo MRI and will be followed to determine whether they complete the MRI. Receives: Device: Prognosia Breast; Device: Mammogram; Device: MRI |
| Arm A: Intervention - MRI + subsequent annual screening mammogram with MRI | Experimental | Consenting and eligible participants will undergo an MRI and subsequent annual screening mammogram with MRI. Receives: Device: Prognosia Breast; Device: Mammogram; Device: MRI |
| Arm B: Regular Care - annual screening mammogram | Active comparator | Consenting and eligible participants will undergo annual screening mammogram per standard of care. Receives: Device: Mammogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of successful recommendations for MRI (Feasibility portion only)
Successful recommendation of MRI is defined as completion of MRI by women referred for MRI.
Measured: Through completion of follow-up (estimated to be 24 months)
2-year detection rate (Randomized Controlled Trial only)
Events including interval breast cancer or invasive breast cancer of a size ≥15mm or being lymph node positive, by arm
Measured: 2 years
Secondary outcomes (5)
Sample size for randomized controlled trial (Feasibility portion only)
At the completion of the feasibility study, the investigators will use the feasibility study data to inform and calculate the sample size for the subsequent randomized 2-arm trial, and if feasible and results are promising, the investigators will propose a randomized 2-arm trial to evaluate the effectiveness of MRI screening in terms of 2-year event rate.
Measured: Through completion of follow-up (estimated to be 24 months)
Number and percentage of recalls (Feasibility portion only)
Measured: Through completion of follow-up (estimated to be 24 months)
Positive predictive value for recall for additional testing and biopsy (Feasibility portion only)
Measured: Through completion of follow-up (estimated to be 24 months)
Number and percentage of recalls (Randomized Controlled Trial only)
Measured: Through completion of follow-up (estimated to be 24 months)
Positive predictive value for recall for additional testing and biopsy (Randomized Controlled Portion only)
Measured: Through completion of follow-up (estimated to be 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start9 Sep 2026
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
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.
- More trials run by Washington University School of MedicineThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The feasibility study will enroll 78 evaluable women and will be sequential enrollment. The sample size for the randomized controlled portion of this study will depend on the results of the feasibility portion of the study and it will be parallel enrollment.
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tabassum Ahmad, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277738
- Sponsor's protocol ID
- 202511123
- Acronym
- PSID
- Status last verified
- Sep 2026
- First submitted
- 2 Dec 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Supplemental Imaging in Women With Dense Breasts (PSID Trial)
- ClinicalTrials.gov ID
- NCT07277738
- Acronym / sponsor ID
- PSID / 202511123
- Conditions
- Breast Cancer, Cancer of the Breast
- Keywords
- Dense breasts, Abbreviated MRI, Risk assessment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 9 Sep 2026 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 11 Dec 2025 (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.
Recent research has shown that, among women with extremely dense breasts and normal results on mammogram, magnetic resonance imaging (MRI) use has significantly reduced the occurrence of breast cancer that is diagnosed during the time between two regular screening mammograms (also known as interval cancers).
The investigators have developed and validated an approach to use the whole mammogram image, develop a mammogram risk score (MRS), and calibrate this to the SEER breast cancer incidence rates for US women. This model (Prognosia Breast) generates an absolute 5-year risk of breast cancer and classifies approximately 5.7% of the population as high risk using the ASCO 3% cut point as used for endocrine therapy to reduce risk. Follow-up generates an incidence of 25.2 cases per 1,000 women per year.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The feasibility study will enroll 78 evaluable women and will be sequential enrollment. The sample size for the randomized controlled portion of this study will depend on the results of the feasibility portion of the study and it will be parallel enrollment.
| Arm | Type | Receives |
|---|---|---|
| Feasibility: Recommended MRI | Experimental | Device: Prognosia Breast, Device: Mammogram, Device: MRIConsenting and eligible participants will be recommended to undergo MRI and will be followed to determine whether they complete the MRI. |
| Arm A: Intervention - MRI + subsequent annual screening mammogram with MRI | Experimental | Device: Prognosia Breast, Device: Mammogram, Device: MRIConsenting and eligible participants will undergo an MRI and subsequent annual screening mammogram with MRI. |
| Arm B: Regular Care - annual screening mammogram | Active comparator | Device: MammogramConsenting and eligible participants will undergo annual screening mammogram per standard of care. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Normal screening mammogram within 90 days prior to enrollment. Bi-Rads of 1 or 2.
- Dense breasts, either:
- Assigned female at birth.
- Between 40 to 74 years of age (inclusive).
- Ability to understand and willingness to sign an IRB approved written informed consent document.
Key exclusion criteria (8 listed)
- Screening mammogram with BI-Rads of 0.
- Contraindication to MRI with contrast (e.g. claustrophobia, metal objects in the body, known sensitivity/allergy to gadolinium).
- Prior or concurrent malignancy whose natural history has the potential to interfere with the study intervention (breast cancer or non-classic LCIS). Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.
- Prior MRI screening of the breast.
- Known to be BRCA 1/2 positive or presence of any other known high penetrance genetic marker.
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 |
|---|---|---|
| Prognosia BreastAlso: MRS, Mammogram absolute risk scoreThe risk output from this algorithm is calibrated to US Surveillance, Epidemiology, and End Results (SEER) 5-year risk and so estimates for each woman the personal 5-year risk. | Device | Arm A: Intervention - MRI + subsequent annual screening mammogram with MRI, Feasibility: Recommended MRI |
| MammogramStandard of care annual screening mammogram | Device | Arm A: Intervention - MRI + subsequent annual screening mammogram with MRI, Arm B: Regular Care - annual screening mammogram, Feasibility: Recommended MRI |
| MRIAlso: Magnetic resonance imagingMRI at the time of annual screening mammogram | Device | Arm A: Intervention - MRI + subsequent annual screening mammogram with MRI, Feasibility: Recommended MRI |
Primary outcome
Number of successful recommendations for MRI (Feasibility portion only)
Time frame: Through completion of follow-up (estimated to be 24 months)
Successful recommendation of MRI is defined as completion of MRI by women referred for MRI.
2-year detection rate (Randomized Controlled Trial only)
Time frame: 2 years
Events including interval breast cancer or invasive breast cancer of a size ≥15mm or being lymph node positive, by arm
5 secondary outcomes
Sample size for randomized controlled trial (Feasibility portion only)
Time frame: Through completion of follow-up (estimated to be 24 months)
Number and percentage of recalls (Feasibility portion only)
Time frame: Through completion of follow-up (estimated to be 24 months)
Positive predictive value for recall for additional testing and biopsy (Feasibility portion only)
Time frame: Through completion of follow-up (estimated to be 24 months)
Number and percentage of recalls (Randomized Controlled Trial only)
Time frame: Through completion of follow-up (estimated to be 24 months)
Positive predictive value for recall for additional testing and biopsy (Randomized Controlled Portion only)
Time frame: Through completion of follow-up (estimated to be 24 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Tabassum Ahmad, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prognosia Breast, Mammogram and MRI in people with Breast Cancer and Cancer of the Breast, run by Washington University School of Medicine 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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 16 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tabassum Ahmad, M.D. (314-474-7696, ahmad.tabassum@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of successful recommendations for MRI (Feasibility portion only) (time frame: Through completion of follow-up (estimated to be 24 months)). The study lists 2 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 16 Sep 2026.