Breast CancerMammoViewNCT07443579
Optimal Mammography View Sequencing in Women With a History of Breast Cancer Undergoing Surveillance Mammography
A study testing Mammography View Sequencing in people with Breast Cancer and Breast Cancer Recurrence, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial summary
This prospective, single-centre, parallel-group randomised controlled trial evaluates the optimal sequencing of mammography views in women with a history of breast cancer undergoing surveillance mammography. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer Recurrence, Post Treatment Surveillance
- What is being tested?
- Mammography View Sequencing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteIreland
- Study dates
- 24 Feb 2026to 31 Dec 2030
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18 years or older History of breast cancer treated with breast-conserving surgery (wide local excision) Undergoing first annual surveillance mammogram following completion of surgery and radiotherapy Within five years of breast cancer treatment May have history of whole-breast or partial-breast radiotherapy May have history of axillary surgery Able and willing to provide informed consent
Who cannot join
- Male patients Patients younger than 18 years History of mastectomy History of bilateral wide local excision Lack of capacity to provide informed consent More than five years since completion of breast cancer treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
Beaumont RCSI Cancer Centre
Beaumont, Dublin, D09V2N0
Aisling Hegarty, 0035317977800, Aislinghegarty@rcsi.ie
Aisling Hegarty, 017977800, Aislinghegarty@rcsi.ie
About this study
This prospective, single-centre, parallel-group randomised controlled trial evaluates the optimal sequencing of mammography views in women with a history of breast cancer undergoing surveillance mammography. Women treated with breast-conserving surgery within the previous five years will be randomised 1:1:1:1 to one of four mammography view sequencing groups.
The primary objective is to compare patient-reported pain and satisfaction across sequencing groups. Secondary objectives include comparison of image quality (PGMI scoring), compression force, and breast thickness.
A total of 400 participants will be enrolled at Beaumont Hospital Breast Care Centre over 2.5 years.
Read the detailed description
Women with a history of breast cancer routinely undergo annual surveillance mammography following breast-conserving surgery and radiotherapy. Standard mammography includes mediolateral oblique (MLO) and craniocaudal (CC) views of each breast. However, there is limited evidence regarding whether the order in which these views are obtained affects patient experience or image quality.
This study randomises 400 women (1:1:1:1) to four different view sequencing protocols:
- Untreated MLO --- Treated MLO --- Untreated CC --- Treated CC
- Untreated CC --- Treated CC --- Untreated MLO --- Treated MLO
- Treated MLO --- Untreated MLO --- Treated CC --- Untreated CC
- Treated CC --- Untreated CC --- Treated MLO --- Untreated MLO
Pain is assessed using a visual analogue scale (VAS) before and after mammography. Patient satisfaction is measured using a post-procedure questionnaire. Image quality will be assessed retrospectively using PGMI scoring by two radiologists. Compression force and breast thickness will also be recorded.
The study uses an intention-to-treat analysis framework.
- Being tested
- Mammography View Sequencing
- Keywords
- Surveillance Mammography, Mammography View Sequencing, Mammography Technique, Breast Imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mammography View SequencingProcedure or surgery
Standard surveillance mammography consisting of MLO and CC views of both treated and untreated breasts. Participants are randomised to one of four predefined sequences determining the order in which views are obtained. No additional imaging beyond standard of care is performed.
| Study group | Role | What they receive |
|---|---|---|
| Untreated MLO First | Experimental | Participants undergo surveillance mammography in the following sequence: Untreated mediolateral oblique (MLO), Treated MLO, Untreated craniocaudal (CC), Treated CC. Receives: Procedure: Mammography View Sequencing |
| Untreated CC First | Experimental | Participants undergo surveillance mammography in the following sequence: Untreated CC, Treated CC, Untreated MLO, Treated MLO. Receives: Procedure: Mammography View Sequencing |
| Treated MLO First | Experimental | Participants undergo surveillance mammography in the following sequence: Treated MLO, Untreated MLO, Treated CC, Untreated CC. Receives: Procedure: Mammography View Sequencing |
| Treated CC First | Experimental | Participants undergo surveillance mammography in the following sequence: Treated CC, Untreated CC, Treated MLO, Untreated MLO. Receives: Procedure: Mammography View Sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient-Reported Pain Score During Mammography
Pain will be measured using a 10-point Visual Analogue Scale (VAS). Pain scores will be recorded immediately prior to mammography and immediately following completion of mammography. The primary analysis will compare post-procedure pain scores across the four randomised sequencing groups.
Measured: Immediately before and immediately after mammography (same study visit)
Patient Satisfaction Following Mammography
Patient satisfaction will be assessed immediately after mammography using a structured electronic questionnaire administered via MS Forms. Responses will be compared across the four sequencing groups.
Measured: Immediately after mammography (same study visit)
Secondary outcomes (5)
Image Quality (PGMI Score)
Image quality will be assessed retrospectively using the PGMI (Perfect, Good, Moderate, Inadequate) scoring system by two radiologists. PGMI scores will be compared across sequencing groups.
Measured: Following image acquisition (retrospective review after mammography during normal reporting timeframe institutionally)
Compression Force During Mammography
Compression force applied during mammography will be recorded in Newtons from the mammography unit and compared across sequencing groups.
Measured: During mammography (same study visit)
Breast Thickness During Mammography
Compressed breast thickness will be recorded in millimetres from the mammography system and compared across sequencing groups.
Measured: During mammography (same study visit)
Mean Glandular Radiation Dose
Mean glandular dose (MGD) will be recorded from the mammography unit for each participant and compared across sequencing groups.
Measured: During mammography (same study visit)
Duration of Mammography Procedure
Total time taken to complete mammography will be recorded in minutes and compared across sequencing groups.
Measured: During mammography (same study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start24 Feb 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomised in a 1:1:1:1 ratio to one of four mammography view sequencing groups. Each group undergoes standard surveillance mammography consisting of mediolateral oblique (MLO) and craniocaudal (CC) views of both treated and untreated breasts, performed in a different predefined sequence. The intervention involves the order in which views are obtained. All participants receive the same imaging views; only the sequence differs. There is no crossover between groups. Analysis will be conducted on an intention-to-treat basis.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443579
- Sponsor's protocol ID
- 25-49
- Acronym
- MammoView
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Mammography View Sequencing in Women With a History of Breast Cancer Undergoing Surveillance Mammography
- ClinicalTrials.gov ID
- NCT07443579
- Acronym / sponsor ID
- MammoView / 25-49
- Keywords
- Surveillance Mammography, Mammography View Sequencing, Mammography Technique, Breast Imaging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 2 Mar 2026 (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.
This prospective, single-centre, parallel-group randomised controlled trial evaluates the optimal sequencing of mammography views in women with a history of breast cancer undergoing surveillance mammography. Women treated with breast-conserving surgery within the previous five years will be randomised 1:1:1:1 to one of four mammography view sequencing groups.
The primary objective is to compare patient-reported pain and satisfaction across sequencing groups. Secondary objectives include comparison of image quality (PGMI scoring), compression force, and breast thickness.
A total of 400 participants will be enrolled at Beaumont Hospital Breast Care Centre over 2.5 years.
Detailed description
Women with a history of breast cancer routinely undergo annual surveillance mammography following breast-conserving surgery and radiotherapy. Standard mammography includes mediolateral oblique (MLO) and craniocaudal (CC) views of each breast. However, there is limited evidence regarding whether the order in which these views are obtained affects patient experience or image quality.
This study randomises 400 women (1:1:1:1) to four different view sequencing protocols:
- Untreated MLO --- Treated MLO --- Untreated CC --- Treated CC
- Untreated CC --- Treated CC --- Untreated MLO --- Treated MLO
- Treated MLO --- Untreated MLO --- Treated CC --- Untreated CC
- Treated CC --- Untreated CC --- Treated MLO --- Untreated MLO
Pain is assessed using a visual analogue scale (VAS) before and after mammography. Patient satisfaction is measured using a post-procedure questionnaire. Image quality will be assessed retrospectively using PGMI scoring by two radiologists. Compression force and breast thickness will also be recorded.
The study uses an intention-to-treat analysis framework.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be randomised in a 1:1:1:1 ratio to one of four mammography view sequencing groups. Each group undergoes standard surveillance mammography consisting of mediolateral oblique (MLO) and craniocaudal (CC) views of both treated and untreated breasts, performed in a different predefined sequence. The intervention involves the order in which views are obtained. All participants receive the same imaging views; only the sequence differs. There is no crossover between groups. Analysis will be conducted on an intention-to-treat basis.
| Arm | Type | Receives |
|---|---|---|
| Untreated MLO First | Experimental | Procedure: Mammography View SequencingParticipants undergo surveillance mammography in the following sequence: Untreated mediolateral oblique (MLO), Treated MLO, Untreated craniocaudal (CC), Treated CC. |
| Untreated CC First | Experimental | Procedure: Mammography View SequencingParticipants undergo surveillance mammography in the following sequence: Untreated CC, Treated CC, Untreated MLO, Treated MLO. |
| Treated MLO First | Experimental | Procedure: Mammography View SequencingParticipants undergo surveillance mammography in the following sequence: Treated MLO, Untreated MLO, Treated CC, Untreated CC. |
| Treated CC First | Experimental | Procedure: Mammography View SequencingParticipants undergo surveillance mammography in the following sequence: Treated CC, Untreated CC, Treated MLO, Untreated MLO. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female patients aged 18 years or older History of breast cancer treated with breast-conserving surgery (wide local excision) Undergoing first annual surveillance mammogram following completion of surgery and radiotherapy Within five years of breast cancer treatment May have history of whole-breast or partial-breast radiotherapy May have history of axillary surgery Able and willing to provide informed consent
Key exclusion criteria (1 listed)
- Male patients Patients younger than 18 years History of mastectomy History of bilateral wide local excision Lack of capacity to provide informed consent More than five years since completion of breast cancer treatment
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 |
|---|---|---|
| Mammography View SequencingStandard surveillance mammography consisting of MLO and CC views of both treated and untreated breasts. Participants are randomised to one of four predefined sequences determining the order in which views are obtained. No additional imaging beyond standard of care is performed. | Procedure or surgery | Treated CC First, Treated MLO First, Untreated CC First, Untreated MLO First |
Primary outcome
Change in Patient-Reported Pain Score During Mammography
Time frame: Immediately before and immediately after mammography (same study visit)
Pain will be measured using a 10-point Visual Analogue Scale (VAS). Pain scores will be recorded immediately prior to mammography and immediately following completion of mammography. The primary analysis will compare post-procedure pain scores across the four randomised sequencing groups.
Patient Satisfaction Following Mammography
Time frame: Immediately after mammography (same study visit)
Patient satisfaction will be assessed immediately after mammography using a structured electronic questionnaire administered via MS Forms. Responses will be compared across the four sequencing groups.
5 secondary outcomes
Image Quality (PGMI Score)
Time frame: Following image acquisition (retrospective review after mammography during normal reporting timeframe institutionally)
Compression Force During Mammography
Time frame: During mammography (same study visit)
Breast Thickness During Mammography
Time frame: During mammography (same study visit)
Mean Glandular Radiation Dose
Time frame: During mammography (same study visit)
Duration of Mammography Procedure
Time frame: During mammography (same study visit)
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 2 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mammography View Sequencing in people with Breast Cancer and Breast Cancer Recurrence, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
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 1 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: looking for participants now, as of the sponsor's last update on 2 Mar 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 Ireland. 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 Prof Nuala Healy (+35318093000, nualahealy@rcsi.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient-Reported Pain Score During Mammography (time frame: Immediately before and immediately after mammography (same study visit)). 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 2 Mar 2026.