Breast CancerSEED02NCT05942118
Comparison Between ROLL Versus Magnetic Seed for Preoperative Localization of Non-palpable Breast Lesion by Randomized Clinical Study.
An observational study of Breast Cancer, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
Several localization techniques are now in use for localization of non-palpable breast lesions. Several studies have compared wire guided localization (WGL), which has been for years the gold standard for non-palpable breast lesions' localization, with more modern techniques. 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 conservative surgery
- Type of treatment
- Surgery or procedure
- How many people
- 262 participants
- Where
- 1 siteItaly
- Study dates
- 31 May 2023to 31 May 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 patients with non-palpable lesions candidated for surgery
Who may be able to join
- Female;
- Non-palpable breast lesions;
- Indication to lesion's surgical excision (lumpectomy, quadrantectomy)
- Preoperative diagnosis on histology or cytology of borderline lesion (B3 or C3) or malignant lesion (B4-B5 or C4-C5);
- Written informed consent.
Who cannot join
- Benign lesion at diagnosis on preoperative core biopsy (B2) or fine needle aspiration (C2);
- Clinically palpable breast lesion;
- Breast lesion localization for planned neoadjuvant chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Monocentric, Prospective, Randomized Clinical Study Comparing ROLL (Radioguided Occult Lesion Localization) With Magnetic Markers for Preoperative Localization of Non-palpable Breast Lesions in Patients Undergoing Breast Conservative Surgery.
Several localization techniques are now in use for localization of non-palpable breast lesions. Several studies have compared wire guided localization (WGL), which has been for years the gold standard for non-palpable breast lesions' localization, with more modern techniques. Scientific evidence supports the efficacy of the new "wire-free" techniques, which appear to be comparable to the WGL in terms of safe surgical resection, while overcoming limitations associated with logistic difficulties and patient discomfort. There is still limited data in literature on the comparative effectiveness of these modern techniques, and there is no strong evidence that one is superior to the others. In particular, no randomized trials of comparison between ROLL and magnetic seed localization are currently available. The aim of this randomized study is to compare ROLL with magnetic seed to assess their efficacy for non-palpable breast lesions' localization.
- Conditions
- Breast Cancer
- Being tested
- Breast conservative 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 conservative surgeryProcedure or surgery
Every patients with non-palpable breast lesion will undergo to conservative breast surgery after lesion's localization
| Study group | Role | What they receive |
|---|---|---|
| ROLL | Prior to surgery, an ultrasound-guided localization will be performed and albumin marked with Technetium 99m will be injected close to the tumor and in the subareolar area. During surgery, a specific probe will be used to locate the lesion and sentinel lymph node. Receives: Procedure: Breast conservative surgery | |
| SEED | During diagnostic biopsy or prior to surgery, a magnetic clip will be placed in the breast lesion; during surgery, localization will be performed using a specific probe, while sentinel lymph node localisation, when needed, will be performed even with indocyanine green dye (ICG) or methylene blue dye Receives: Procedure: Breast conservative 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 disease-free ("no ink on tumor" for invasive cancer and margin of 2 mm for in situ-carcinoma).
Measured: 3 years
Secondary outcomes (7)
Excess breast resection
Excess breast resection calculated by the "calculated resection ratio" (CRR) as follow: CRR = total resection volume/optimal resection volume
Measured: 3 years
Surgery Time
Surgery duration (hours)
Measured: 3 years
Hospitalization days
Number of hospitalization's days
Measured: 3 years
Complications
Complications occurred after biopsy or surgery
Measured: 3 years
Reintervention
Reintervention rates
Measured: 3 years
Cost-effectiveness analysis
Cost-effectiveness analysis in different subgroups
Measured: 3 years
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 start31 May 2023
- Primary completion31 May 2026
- Study completion31 May 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.
- 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
- Prospective
- Enrolment
- 262 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
- NCT05942118
- Sponsor's protocol ID
- 2778
- Acronym
- SEED02
- Status last verified
- May 2026
- First submitted
- 23 Jun 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- 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 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Monocentric, Prospective, Randomized Clinical Study Comparing ROLL (Radioguided Occult Lesion Localization) With Magnetic Markers for Preoperative Localization of Non-palpable Breast Lesions in Patients Undergoing Breast Conservative Surgery.
- ClinicalTrials.gov ID
- NCT05942118
- Acronym / sponsor ID
- SEED02 / 2778
- Conditions
- Breast Cancer
- Keywords
- Non-palpable breast lesion
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 262 participants (estimated)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 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.
Several localization techniques are now in use for localization of non-palpable breast lesions. Several studies have compared wire guided localization (WGL), which has been for years the gold standard for non-palpable breast lesions' localization, with more modern techniques. Scientific evidence supports the efficacy of the new "wire-free" techniques, which appear to be comparable to the WGL in terms of safe surgical resection, while overcoming limitations associated with logistic difficulties and patient discomfort. There is still limited data in literature on the comparative effectiveness of these modern techniques, and there is no strong evidence that one is superior to the others. In particular, no randomized trials of comparison between ROLL and magnetic seed localization are currently available. The aim of this randomized study is to compare ROLL with magnetic seed to assess their efficacy for non-palpable breast lesions' localization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ROLL | – | Procedure: Breast conservative surgeryPrior to surgery, an ultrasound-guided localization will be performed and albumin marked with Technetium 99m will be injected close to the tumor and in the subareolar area. During surgery, a specific probe will be used to locate the lesion and sentinel lymph node. |
| SEED | – | Procedure: Breast conservative surgeryDuring diagnostic biopsy or prior to surgery, a magnetic clip will be placed in the breast lesion; during surgery, localization will be performed using a specific probe, while sentinel lymph node localisation, when needed, will be performed even with indocyanine green dye (ICG) or methylene blue dye |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients with non-palpable lesions candidated for surgery
Key inclusion criteria (5 listed)
- Female;
- Non-palpable breast lesions;
- Indication to lesion's surgical excision (lumpectomy, quadrantectomy)
- Preoperative diagnosis on histology or cytology of borderline lesion (B3 or C3) or malignant lesion (B4-B5 or C4-C5);
- Written informed consent.
Key exclusion criteria (3 listed)
- Benign lesion at diagnosis on preoperative core biopsy (B2) or fine needle aspiration (C2);
- Clinically palpable breast lesion;
- Breast lesion localization for planned 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 conservative surgeryEvery patients with non-palpable breast lesion will undergo to conservative breast surgery after lesion's localization | Procedure or surgery | ROLL, SEED |
Primary outcome
Free-surgical margins
Time frame: 3 years
Number of surgical procedures in which surgical margins are disease-free ("no ink on tumor" for invasive cancer and margin of 2 mm for in situ-carcinoma).
7 secondary outcomes
Excess breast resection
Time frame: 3 years
Surgery Time
Time frame: 3 years
Hospitalization days
Time frame: 3 years
Complications
Time frame: 3 years
Reintervention
Time frame: 3 years
Cost-effectiveness analysis
Time frame: 3 years
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.
- 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. 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 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: 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: 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 23 Jun 2026.