Breast Cancer SurgeryNCT03737266
Comparison of Conventional With Sonography Assisted Breast Surgery After Neoadjuvant Chemotherapy
A study testing Sonographically assisted breast surgery and Conventional breast surgery in people with Breast Cancer Surgery, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Aim of the study is to investigate whether intra-surgical visualisation of malignoma reduces the resection rate in the case of R1 resection compared to the procedure without sonographic visualisation Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer Surgery
- What is being tested?
- Sonographically 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
- 137 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2018to 1 Jan 2023
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 80 years
- Female
- Presurgical validated breast cancer
- Unifocal to multifocal findings
- Palpable and/o non-palpable findings
- Neoadjuvant chemotherapy
Show all 11Show fewer
- Indication for breast conserving therapy
- General operation ability and anesthesia ability
- Consent to conventional breast conserving breast surgery with wire marking
- Ability and will to follow the study conditions
- Written declaration of consent after clarification
Who cannot join
- Sonographically not clearly delineate resection areal
- Simultaneous participation in other interventional trials that interfere with this study at the investigator's discretion
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department for Women's Health
Tübingen, Baden-Wurttemberg, 72086
About this study
Official title: Sonographically Assisted Versus Conventionally Breast Surgery in Breast Cancer Patients With an Indication for Breast Conserving Surgery After Neoadjuvant Chemotherapy
Aim of the study is to investigate whether intra-surgical visualisation of malignoma reduces the resection rate in the case of R1 resection compared to the procedure without sonographic visualisation
- Conditions
- Breast Cancer Surgery
- Being tested
- Sonographically 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.
Sonographically assisted breast surgeryProcedure or surgery
Sonography
Conventional breast surgeryProcedure or surgery
Conventional
| Study group | Role | What they receive |
|---|---|---|
| Sonographically assisted breast surgery | Experimental | Sonography assisted breast surgery Receives: Procedure: Sonographically assisted breast surgery; Procedure: Conventional breast surgery |
| Conventional breast surgery | Active comparator | Conventional breast surgery Receives: Procedure: Sonographically assisted breast surgery; Procedure: Conventional breast surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
proportion of surgical procedures for cancer in which the surgeon is able to completely remove all detectable tumor tissue with negative margins, indicating that no cancer cells remain in the surgical site
Measured: 3 years
Secondary outcomes (2)
Weight of primary resedate
weight of the tumor tissue removed during surgery for cancer
Measured: 3 years
Time for cut and sew
duration of the surgical procedure from the initial incision to the completion of the closure of the incision site
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 Nov 2018
- Study start1 Oct 2018
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus Hahn, Prof. Dr., Principal investigator, Department of Women's Health, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737266
- Sponsor's protocol ID
- Seno_Ex_MAC 003
- Status last verified
- Feb 2024
- First submitted
- 16 Oct 2018
- Last updated
- 14 Feb 2024
- 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 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographically Assisted Versus Conventionally Breast Surgery in Breast Cancer Patients With an Indication for Breast Conserving Surgery After Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT03737266
- Acronym / sponsor ID
- Seno_Ex_MAC 003
- Conditions
- Breast Cancer Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 9 Nov 2018 (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.
Aim of the study is to investigate whether intra-surgical visualisation of malignoma reduces the resection rate in the case of R1 resection compared to the procedure without sonographic visualisation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sonographically assisted breast surgery | Experimental | Procedure: Sonographically assisted breast surgery, Procedure: Conventional breast surgerySonography assisted breast surgery |
| Conventional breast surgery | Active comparator | Procedure: Sonographically assisted breast surgery, Procedure: Conventional breast surgeryConventional breast surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 to 80 years
- Female
- Presurgical validated breast cancer
- Unifocal to multifocal findings
- Palpable and/o non-palpable findings
Key exclusion criteria (2 listed)
- Sonographically not clearly delineate resection areal
- Simultaneous participation in other interventional trials that interfere with this study at the investigator's discretion
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 |
|---|---|---|
| Sonographically assisted breast surgerySonography | Procedure or surgery | Conventional breast surgery, Sonographically assisted breast surgery |
| Conventional breast surgeryConventional | Procedure or surgery | Conventional breast surgery, Sonographically assisted breast surgery |
Primary outcome
R0 resection rate
Time frame: 3 years
proportion of surgical procedures for cancer in which the surgeon is able to completely remove all detectable tumor tissue with negative margins, indicating that no cancer cells remain in the surgical site
2 secondary outcomes
Weight of primary resedate
Time frame: 3 years
Time for cut and sew
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 14 Feb 2024.
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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.
Markus Hahn, Prof. Dr. principal investigator
Department of Women's Health, University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonographically assisted breast surgery and Conventional breast surgery in people with Breast Cancer 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 11 inclusion and 2 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 14 Feb 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?
R0 resection rate (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 14 Feb 2024.