Breast CancerMAC004NCT07519668
Retrospective Evaluation of Ultrasound-assisted Tumor Surgery in Breast-conserving Therapy
An observational study of Breast Cancer, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The aim of this study is to evaluate whether standardizing intraoperative ultrasound (IOUS) with the "Tübingen Ultrasound Ruler" reduces R1 resection rates in breast-conserving surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 273 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2020to 31 Dec 2023
- Phase
- Observational
- 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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All patients who underwent breast-conserving mammosurgery using the standardized ultrasound ruler technique from 2020 to 2023, regardless of tumor biology, microcalcifications, focality, or primary chemotherapy.
Who may be able to join
- Age at least 18 years and no more than 80 years (inclusive)
- Preoperatively histologically confirmed breast cancer, detectable by ultrasound
- Unifocal to multifocal findings
- Palpable and/or non-palpable findings
- Indication for breast-conserving therapy (BCT)
Who cannot join
- Sonographically ambiguous findings
- Multicentricity
- Status after neoadjuvant chemotherapy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department for Women's Health
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Retrospective Evaluation of the R1/ Post-resection Rate With Intraoperative Measurement of the Target Volume Using Ultrasound by a Surgeon (Ultrasound-assisted Tumor Surgery) as Part of Breast-conserving Therapy in Breast Cancer
The aim of this study is to evaluate whether standardizing intraoperative ultrasound (IOUS) with the "Tübingen Ultrasound Ruler" reduces R1 resection rates in breast-conserving surgery.
- Conditions
- Breast Cancer
- Keywords
- Breast-Conserving Surgery, Intraoperative ultrasound
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Uni- or Bilateral Ductal Carcinoma in Situ (DCIS) or Invasive Breast Cancer | This retrospective, single-center study included 313 surgical procedures performed on 304 patients between January 2020 and December 2023. The patients underwent breast-conserving surgery (BCS) for unilateral or bilateral ductal carcinoma in situ (DCIS) or invasive breast cancer. All surgeries were performed by a single surgeon. |
What is being measured
The primary outcome is the main question the study is designed to answer.
R1 resection rates
In this retrospective study, R1 resections were defined as cases requiring a follow-up surgery due to incomplete tumor removal.
Measured: 3 years
Secondary outcomes (3)
Weight of main specimen
The weight of the main specimen was recorded immediately after excision at the time of surgical removal.
Measured: Day of excision
Duration of surgery
Measured: During surgery
Number of Shavings
Number of shavings was recorded intraoperatively, with each shaving representing additional tissue removed to achieve clear margins.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Jan 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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 Hospital TuebingenThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519668
- Sponsor's protocol ID
- SenoEx_MAC004
- Acronym
- MAC004
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of the R1/ Post-resection Rate With Intraoperative Measurement of the Target Volume Using Ultrasound by a Surgeon (Ultrasound-assisted Tumor Surgery) as Part of Breast-conserving Therapy in Breast Cancer
- ClinicalTrials.gov ID
- NCT07519668
- Acronym / sponsor ID
- MAC004 / SenoEx_MAC004
- Conditions
- Breast Cancer
- Keywords
- Breast-Conserving Surgery, Intraoperative ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 9 Apr 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.
The aim of this study is to evaluate whether standardizing intraoperative ultrasound (IOUS) with the "Tübingen Ultrasound Ruler" reduces R1 resection rates in breast-conserving surgery.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Uni- or Bilateral Ductal Carcinoma in Situ (DCIS) or Invasive Breast Cancer | – | –This retrospective, single-center study included 313 surgical procedures performed on 304 patients between January 2020 and December 2023. The patients underwent breast-conserving surgery (BCS) for unilateral or bilateral ductal carcinoma in situ (DCIS) or invasive breast cancer. All surgeries were performed by a single surgeon. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent breast-conserving mammosurgery using the standardized ultrasound ruler technique from 2020 to 2023, regardless of tumor biology, microcalcifications, focality, or primary chemotherapy.
Key inclusion criteria (5 listed)
- Age at least 18 years and no more than 80 years (inclusive)
- Preoperatively histologically confirmed breast cancer, detectable by ultrasound
- Unifocal to multifocal findings
- Palpable and/or non-palpable findings
- Indication for breast-conserving therapy (BCT)
Key exclusion criteria (3 listed)
- Sonographically ambiguous findings
- Multicentricity
- Status after neoadjuvant chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
R1 resection rates
Time frame: 3 years
In this retrospective study, R1 resections were defined as cases requiring a follow-up surgery due to incomplete tumor removal.
3 secondary outcomes
Weight of main specimen
Time frame: Day of excision
Duration of surgery
Time frame: During surgery
Number of Shavings
Time frame: During surgery
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 9 Apr 2026.
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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?
An observational study of Breast Cancer, run by University Hospital Tuebingen at 1 site in Germany.
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 5 inclusion and 3 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 9 Apr 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 Germany. 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?
R1 resection rates (time frame: 3 years). 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 9 Apr 2026.