New seed method may sharpen breast cancer surgery
NCT ID NCT02759133
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested two methods for marking non-palpable breast tumors before surgery: a tiny iodine seed versus a standard metal wire. 350 women with early-stage breast cancer took part. The goal was to see if the seed method leads to cleaner surgical margins, potentially reducing the need for repeat surgeries.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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350 people
The number who actually took part.
- Start date
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Jun 2016
- Finished
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Aug 2023
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients aged 18 or over * Patients suffering from unifocal or in situ invasive or ductal breast cancer proven by anatomopathologic analysis (biopsy). * Non-palpable tumor measuring at least 5 mm (minimum size deemed sufficient for the lesion to be visible by ultrasound) and ≤ 30 mm, visible by ultrasound and constituting a mass. * Patients needing conservative first surgery management by preoperative tumor localization. For women of childbearing age, an effective contraceptive is mandatory throughout the study and up to 6 months post-operatively. * Patients who have been made aware of the information sheet and have given their written signed informed consent. * Patients benefitting from social health insurance coverage. Exclusion Criteria: * Patients with a history of homolateral breast cancer. * Patients who have undergone neoadjuvant chemotherapy. * Multifocal or multicentric cancer. * Metastatic breast cancer. * Cancer presenting in the form of microcalcifications with no visible mass. * Vulnerable patients: pregnant or breastfeeding women, women deprived of their freedom by administrative or judicial decree, adults subject to a legal protection order or unable to give their consent.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre Antoine LACASSAGNE
Nice, 06000, France
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