Breast CancerNCT06489665
Imaging Quality and Potential Clinical Relevance of Phase Contrast Mammography In-vivo: a Single-center, Prospective Study
An observational study of Breast Cancer and Microcalcification, run by University of Zurich at 2 sites in Switzerland.
Trial summary
Conventional mammography, breast sonography and breast MRI have specific weaknesses. In particular, mammography has a low sensitivity for the detection of mammary carcinoma in patients with a dense breast. Phase contrast mammography could help to overcome some of these limitations. Observational study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Microcalcification, Image
- What is being tested?
- Experimental Intervention
- How many people
- 350 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 17 Oct 2024to 1 Sep 2030
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who are scheduled to have a mastectomy, tumorectomy or biopsy
Who may be able to join
- >18 years
- Mastectomy, tumorectomy or biopsy planned
- Informed consent of the patient
- >18 years
- BI-RADS 5 (highly suggestive of malignancy at ultrasound or mammography) or 6 (known biopsy proven malignancy);
- Scheduled for mastectomy or breast conserving surgery with radiotherapy.
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- Informed consent of the patient
- >40 years
- undergoing mammography for screening or diagnostic purpose.
- Informed consent of the patient
Who cannot join
- Breast implants. The women will be asked, if they have a breast-implant.
- Inability to understand the study procedure due to cognitive or linguistic deficits.
- Exclusion criteria for patients, participating in Phase 1 and Phase 2:
- Pregnancy
- Breast-feeding.
- Re-staging after neoadjuvant chemotherapy. Patients who participated in prior research projects with ionizing radiation in the past 12 months
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
University Hospital Zurich - Diagnostic Radiology
Zurich, Canton of Zurich, 8091
Thomas Frauenfelder, PD MD, 0041442551111, thomas.frauenfelder@usz.ch
Thomas Frauenfelder, Prof
- Recruiting
University of Zurich
Zurich
Thomas Frauenfelder, MD
About this study
Official title: Imaging Quality and Potential Clinical Relevance of Phase Contrast
Conventional mammography, breast sonography and breast MRI have specific weaknesses. In particular, mammography has a low sensitivity for the detection of mammary carcinoma in patients with a dense breast. Phase contrast mammography could help to overcome some of these limitations. Observational study.
Read the detailed description
Category C2 Medicine product without CE label.
Objective(s):
Phase 0: Imaging of mastectomy and breast biopsy samples to validate the image quality and radiation dose. Phase 1: Determination of accurate radiation dose in vivo; dose exposure should remain within the range specified in the investigational brochure. Evaluation of cohort size for phase 2. Phase 2: Assessment of the diagnostic performance of phase contrast mammography compared to conventional digital mammography.
Ouctomes: Sensitivity and specificity of phase contrast mammography compared to conventional digital mammography.
Measurements and procedures:
Phase 0: Phase contrast mammography of the mastectomy, tumorectomy or breast biopsy samples is performed after breast surgery in addition to the standard clinical procedures Phase 1: Phase contrast mammography is performed before the operation in case of known breast carcinoma in addition to the standard clinical procedures Phase 2: Phase contrast mammography is performed directly in the clinical routine. The result is compared with the result of the conventional digital mammography and the ultrasound examination.
Number of Participants with Rationale:
Phase 0: expected to be 30 Phase 1: expected to be 20 Phase 2: expected to be 300 (correct number will be defined according to Phase 1)
- Conditions
- Breast Cancer, Microcalcification, Image
- Being tested
- Experimental Intervention
- Keywords
- Mammography
- Medical subject headings
- Breast Neoplasms, Calcinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental InterventionDiagnostic test
Also called control intervention
Mammography in the radiology department is commonly performed using General Electrics Medical Systems Senographe Essential device
| Study group | Role | What they receive |
|---|---|---|
| Mammography finding | Describes the mammography finding in patients prior breast surgery Receives: Diagnostic Test: Experimental Intervention | |
| Bellona | Describes the finding in the breast tissue samples Receives: Diagnostic Test: Experimental Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of PCM compared to FFDM represent the primary outcome since the limited sensitivity of mammography, in particular in patients with dense breasts, represents the major limitation of the currently applied FFDM.
The standard reference will be the histologic specimen after biopsy
Measured: 30 month
Secondary outcomes (1)
Lesion extent will be estimated using both PCM and FFDM. Pathological measurements obtained from the surgical specimen will be used as standard of reference.
The aim is to evaluate if PCM, due to the expected improved visibility of the lesions, can allow for a better estimation of lesion extent with subsequent benefit on the preoperative planning.
Measured: 30 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start17 Oct 2024
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 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.
- More trials run by University of ZurichThe 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Proton Therapy, Paul Scherrer Institute, Villigen,Switzerland, GratXray AG
- Responsible party
- Sponsor
- Investigators
- Thomas Frau, Prof, Principal investigator, University Hospital Zurich, DIR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489665
- Sponsor's protocol ID
- 2021-00200
- Status last verified
- Feb 2025
- First submitted
- 28 Jun 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Quality and Potential Clinical Relevance of Phase Contrast
- ClinicalTrials.gov ID
- NCT06489665
- Acronym / sponsor ID
- 2021-00200
- Conditions
- Breast Cancer, Microcalcification, Image
- Keywords
- Mammography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Center for Proton Therapy, Paul Scherrer Institute, Villigen,Switzerland, GratXray AG
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 8 Jul 2024 (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.
Conventional mammography, breast sonography and breast MRI have specific weaknesses. In particular, mammography has a low sensitivity for the detection of mammary carcinoma in patients with a dense breast. Phase contrast mammography could help to overcome some of these limitations. Observational study.
Detailed description
Category C2 Medicine product without CE label.
Objective(s):
Phase 0: Imaging of mastectomy and breast biopsy samples to validate the image quality and radiation dose. Phase 1: Determination of accurate radiation dose in vivo; dose exposure should remain within the range specified in the investigational brochure. Evaluation of cohort size for phase 2. Phase 2: Assessment of the diagnostic performance of phase contrast mammography compared to conventional digital mammography.
Ouctomes: Sensitivity and specificity of phase contrast mammography compared to conventional digital mammography.
Measurements and procedures:
Phase 0: Phase contrast mammography of the mastectomy, tumorectomy or breast biopsy samples is performed after breast surgery in addition to the standard clinical procedures Phase 1: Phase contrast mammography is performed before the operation in case of known breast carcinoma in addition to the standard clinical procedures Phase 2: Phase contrast mammography is performed directly in the clinical routine. The result is compared with the result of the conventional digital mammography and the ultrasound examination.
Number of Participants with Rationale:
Phase 0: expected to be 30 Phase 1: expected to be 20 Phase 2: expected to be 300 (correct number will be defined according to Phase 1)
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mammography finding | – | Diagnostic Test: Experimental InterventionDescribes the mammography finding in patients prior breast surgery |
| Bellona | – | Diagnostic Test: Experimental InterventionDescribes the finding in the breast tissue samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who are scheduled to have a mastectomy, tumorectomy or biopsy
Key inclusion criteria (10 listed)
- >18 years
- BI-RADS 5 (highly suggestive of malignancy at ultrasound or mammography) or 6 (known biopsy proven malignancy);
- Scheduled for mastectomy or breast conserving surgery with radiotherapy.
- Informed consent of the patient
- >40 years
Key exclusion criteria (6 listed)
- Pregnancy
- Breast-feeding.
- Re-staging after neoadjuvant chemotherapy. Patients who participated in prior research projects with ionizing radiation in the past 12 months
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 |
|---|---|---|
| Experimental InterventionAlso: control interventionMammography in the radiology department is commonly performed using General Electrics Medical Systems Senographe Essential device | Diagnostic test | Bellona, Mammography finding |
Primary outcome
Sensitivity and specificity of PCM compared to FFDM represent the primary outcome since the limited sensitivity of mammography, in particular in patients with dense breasts, represents the major limitation of the currently applied FFDM.
Time frame: 30 month
The standard reference will be the histologic specimen after biopsy
1 secondary outcome
Lesion extent will be estimated using both PCM and FFDM. Pathological measurements obtained from the surgical specimen will be used as standard of reference.
Time frame: 30 month
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 5 Feb 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.
Thomas Frau, Prof principal investigator
University Hospital Zurich, DIR
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Microcalcification, run by University of Zurich at 2 sites in Switzerland.
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 10 inclusion and 6 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 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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 Thomas Frauenfelder, Prof (+41 44 255 93 83, thomas.frauenfelder@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of PCM compared to FFDM represent the primary outcome since the limited sensitivity of mammography, in particular in patients with dense breasts, represents the major limitation of the currently applied FFDM. (time frame: 30 month). 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 5 Feb 2025.