Breast CancerSEED01NCT05942092
ROLL Versus Magnetic Seed for Preoperative Localization of Non-palpable Breast Lesion: Comparison Between Techniques.
An observational study of Breast Cancer, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
Nowadays, Breast Conservative Surgery (BCS) is the standard of care for patients affected by early breast lesions. Screening programmes led to an increase of impalpable breast lesion detection rates. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breast conserving surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1,400 participants
- Where
- 1 siteItaly
- Study dates
- 26 Apr 2023to 30 Sep 2028
- 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 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer women with non-palpable lesions
Who may be able to join
- Female patients between 18 and 85 years who underwent to breast conservative surgery for non-palpable occult breast lesions;
- Intraoperative localization of breast lesion with ROLL or magnetic seed;
- Preoperative diagnosis on histology or cytology of borderline lesion (B3 or C3) or malignant lesion (B4-B5 or C4-C5).
Who cannot join
- B2 or C2 at preoperative needle breast biopsy or fine needle breast aspiration.
- Breast tumor localization with clip for neoadjuvant chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Multicentric Clinical Study Comparing Radioguided Occult Lesion Localization (ROLL) and Magnetic Seed in the Intraoperative Localization of Non-palpable Breast Lesions During Breast Conservative Surgery.
Nowadays, Breast Conservative Surgery (BCS) is the standard of care for patients affected by early breast lesions. Screening programmes led to an increase of impalpable breast lesion detection rates. These patients are often eligible for BCS and an accurate preoperative localization technique for the detection of the lesion is required in order to guarantee a safe surgical excision.
The primary goal of BCS is to obtain a complete resection of the tumor with disease-free surgical margins. The presence of tumor on surgical margins on postoperative histological examination of the specimen increases the risk of local recurrence and it requires a surgical re-excision. For all these reasons different techniques for localization of occult breast lesions have been developed over time. Since '70s, the wire guided localization (WGL) technique has represented the gold standard technique; however, it has several limitations such as wire migration or fracture and patient's referred discomfort related to wire placement. Other techniques have been proposed such as the ROLL and magnetic seeds.
Read more
The ROLL consists of the injection of a radioactive substance into the breast lesion and the localization during surgery is allowed by using a handheld gamma probe. Limitations of this technique are represented by the need of radioactive injection the day before surgery with subsequent longer hospitalizations and the possible spread of the radioactive substance into breast tissue leading to larger resections.
The latest technological evolution is represented by magnetic seeds, small devices deployed into the lesion even up to more than 30 days before surgery and identified with a specific magnetic probe during surgery.
Currently there are several studies of comparison between the WGL and the more modern techniques. All of these data claim the effectiveness of the new "wire-free" methodics ensuring a safe surgical resection with tumor-free margins and, in some cases, a better aesthetic result.
Studies of comparison between the modern techniques are limited. There is no scientific evidence of the superiority of magnetic seeds compared to ROLL.
The aim of this retrospective study is to compare ROLL with magnetic seed to assess their efficacy in the localization of non-palpable breast lesions.
- Conditions
- Breast Cancer
- Being tested
- Breast conserving surgery
- Keywords
- Non-palpable breast lesion
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast conserving surgeryProcedure or surgery
Breast conserving surgery after lesion's localization with ROLL or magnetic seed
| Study group | Role | What they receive |
|---|---|---|
| ROLL | Not described Receives: Procedure: Breast conserving surgery | |
| SEED | Not described Receives: Procedure: Breast conserving surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free-surgical margins
Number of surgical procedures in which surgical margins are tumor disease-free ("no ink on tumor" for invasive cancer and margin of 2 mm for in situ-carcinoma).
Measured: 6 months
Secondary outcomes (6)
Excess breast resection
Excess breast resection calculated by the "calculated resection ratio" (CRR=total resection volume/optimal resection volume)
Measured: 6 months
Surgery time
Surgery duration
Measured: 6 months
Hospitalization's days
Number of hospitalization's days
Measured: 6 months
Complications
Complications occurred after biopsy or surgery
Measured: 6 months
Reintervention
Reintervention rates
Measured: 6 months
Follow up
5-years follow-up outcomes
Measured: 5 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start26 Apr 2023
- Primary completion30 Dec 2025
- Study completion30 Sep 2028 (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 Istituti Clinici Scientifici Maugeri SpAThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Corsi, Istituti Clinici Scientifici Maugeri SpA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942092
- Sponsor's protocol ID
- 2755
- Acronym
- SEED01
- Status last verified
- May 2026
- First submitted
- 27 Jun 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Multicentric Clinical Study Comparing Radioguided Occult Lesion Localization (ROLL) and Magnetic Seed in the Intraoperative Localization of Non-palpable Breast Lesions During Breast Conservative Surgery.
- ClinicalTrials.gov ID
- NCT05942092
- Acronym / sponsor ID
- SEED01 / 2755
- Conditions
- Breast Cancer
- Keywords
- Non-palpable breast lesion
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 12 Jul 2023 (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.
Nowadays, Breast Conservative Surgery (BCS) is the standard of care for patients affected by early breast lesions. Screening programmes led to an increase of impalpable breast lesion detection rates. These patients are often eligible for BCS and an accurate preoperative localization technique for the detection of the lesion is required in order to guarantee a safe surgical excision.
The primary goal of BCS is to obtain a complete resection of the tumor with disease-free surgical margins. The presence of tumor on surgical margins on postoperative histological examination of the specimen increases the risk of local recurrence and it requires a surgical re-excision. For all these reasons different techniques for localization of occult breast lesions have been developed over time. Since '70s, the wire guided localization (WGL) technique has represented the gold standard technique; however, it has several limitations such as wire migration or fracture and patient's referred discomfort related to wire placement. Other techniques have been proposed such as the ROLL and magnetic seeds.
The ROLL consists of the injection of a radioactive substance into the breast lesion and the localization during surgery is allowed by using a handheld gamma probe. Limitations of this technique are represented by the need of radioactive injection the day before surgery with subsequent longer hospitalizations and the possible spread of the radioactive substance into breast tissue leading to larger resections.
The latest technological evolution is represented by magnetic seeds, small devices deployed into the lesion even up to more than 30 days before surgery and identified with a specific magnetic probe during surgery.
Currently there are several studies of comparison between the WGL and the more modern techniques. All of these data claim the effectiveness of the new "wire-free" methodics ensuring a safe surgical resection with tumor-free margins and, in some cases, a better aesthetic result.
Studies of comparison between the modern techniques are limited. There is no scientific evidence of the superiority of magnetic seeds compared to ROLL.
The aim of this retrospective study is to compare ROLL with magnetic seed to assess their efficacy in the localization of non-palpable breast lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ROLL | – | Procedure: Breast conserving surgery |
| SEED | – | Procedure: Breast conserving surgery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer women with non-palpable lesions
Key inclusion criteria (3 listed)
- Female patients between 18 and 85 years who underwent to breast conservative surgery for non-palpable occult breast lesions;
- Intraoperative localization of breast lesion with ROLL or magnetic seed;
- Preoperative diagnosis on histology or cytology of borderline lesion (B3 or C3) or malignant lesion (B4-B5 or C4-C5).
Key exclusion criteria (2 listed)
- B2 or C2 at preoperative needle breast biopsy or fine needle breast aspiration.
- Breast tumor localization with clip for 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast conserving surgeryBreast conserving surgery after lesion's localization with ROLL or magnetic seed | Procedure or surgery | ROLL, SEED |
Primary outcome
Free-surgical margins
Time frame: 6 months
Number of surgical procedures in which surgical margins are tumor disease-free ("no ink on tumor" for invasive cancer and margin of 2 mm for in situ-carcinoma).
6 secondary outcomes
Excess breast resection
Time frame: 6 months
Surgery time
Time frame: 6 months
Hospitalization's days
Time frame: 6 months
Complications
Time frame: 6 months
Reintervention
Time frame: 6 months
Follow up
Time frame: 5 years after enrollment
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 23 Jun 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 Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
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 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: under way, not looking for participants, as of the sponsor's last update on 23 Jun 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 Italy. 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?
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?
Free-surgical margins (time frame: 6 months). 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 23 Jun 2026.