Breast SurgeryMAC-001NCT02222675
Conserving Breast Surgery - Comparison of Conventional With Sonography
A study testing Sonography assisted breast surgery and Conventional breast surgery in people with Breast Surgery, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Aim of the study is to test whether surgical removal of a tumor under sonographic control as compared to conventional method reduces the rate of resections and local relapse Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Surgery
- What is being tested?
- Sonography assisted breast surgery and Conventional breast surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2009to May 2015
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 70 years
- Female
- Presurgical validated breast cancer
Who cannot join
- Sonographically not defined report
- Lobular breast cancer
- Extensive ductal carcinoma in situ
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Sonographically Assisted With Conventionally Breast Surgery - Prospective, Randomised, Multicenter, Parallel Group Study With Two Study Arms
Aim of the study is to test whether surgical removal of a tumor under sonographic control as compared to conventional method reduces the rate of resections and local relapse
- Conditions
- Breast Surgery
- Being tested
- Sonography assisted breast surgery, Conventional breast surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonography assisted breast surgeryProcedure or surgery
Conventional breast surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Sonographically assisted breast surgery | Experimental | Sonographically assisted breast surgery Receives: Procedure: Sonography assisted breast surgery |
| Conventional breast surgery | Active comparator | Conventional breast surgery Receives: Procedure: Conventional breast surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of second tumor resections
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startApr 2009
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- University Women's Hospital Tübingen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222675
- Sponsor's protocol ID
- MAC-001_1.1
- Acronym
- MAC-001
- Status last verified
- Jul 2024
- First submitted
- 20 Aug 2014
- Last updated
- 22 Jul 2024
- Results posted
- No
Publications
Hoffmann J, Marx M, Hengstmann A, Seeger H, Oberlechner E, Helms G, Rohm C, Ott C, Wallwiener D, Stabler A, Wiesinger B, Hartkopf AD, Brucker SY, Hahn M. Ultrasound-Assisted Tumor Surgery in Breast Cancer - A Prospective, Randomized, Single-Center Study (MAC 001). Ultraschall Med. 2019 Jun;40(3):326-332. doi: 10.1055/a-0637-1725. Epub 2018 Jul 5.
PubMed 29975969
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sonographically Assisted With Conventionally Breast Surgery - Prospective, Randomised, Multicenter, Parallel Group Study With Two Study Arms
- ClinicalTrials.gov ID
- NCT02222675
- Acronym / sponsor ID
- MAC-001 / MAC-001_1.1
- Conditions
- Breast Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- University Women's Hospital Tübingen
- Study start
- Apr 2009
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 21 Aug 2014 (estimated)
- 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.
Aim of the study is to test whether surgical removal of a tumor under sonographic control as compared to conventional method reduces the rate of resections and local relapse
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sonographically assisted breast surgery | Experimental | Procedure: Sonography assisted breast surgerySonographically assisted breast surgery |
| Conventional breast surgery | Active comparator | Procedure: Conventional breast surgeryConventional breast surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 70 years
- Female
- Presurgical validated breast cancer
Key exclusion criteria (3 listed)
- Sonographically not defined report
- Lobular breast cancer
- Extensive ductal carcinoma in situ
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 |
|---|---|---|
| Sonography assisted breast surgery | Procedure or surgery | Sonographically assisted breast surgery |
| Conventional breast surgery | Procedure or surgery | Conventional breast surgery |
Primary outcome
Rate of second tumor resections
Time frame: Five years
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 22 Jul 2024.
- Derived from this study: PubMed 29975969Hoffmann J, Marx M, Hengstmann A, Seeger H, Oberlechner E, Helms G, Rohm C, Ott C, Wallwiener D, Stabler A, Wiesinger B, Hartkopf AD, Brucker SY, Hahn M. Ultrasound-Assisted Tumor Surgery in Breast Cancer - A Prospective, Randomized, Single-Center Study (MAC 001). Ultraschall Med. 2019 Jun;40(3):326-332. doi: 10.1055/a-0637-1725. Epub 2018 Jul 5.
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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?
A study testing Sonography assisted breast surgery and Conventional breast surgery in people with Breast Surgery, 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 3 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 22 Jul 2024. 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?
Rate of second tumor resections (time frame: Five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02222675, which also lists 1 linked publication.
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 22 Jul 2024.