Postoperative breast MRI in patients undergoing sentinel node biopsy using super paramagnetic iron oxide nanoparticles

The compatibility of POSToperative breast MRI in patients who underwent MAGnetic guided sentinel lymph node biopsy (POSTMAG MRI): a prospective study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN85167182

Enrollment

Registered

2018-01-16

Start date

2017-09-01

Completion date

Unknown

Last updated

2018-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer Cancer Malignant neoplasm of breast

Interventions

Women undergoing BCS will take part in the study. After specimen excision, the background magnetic count will be registered. Postoperative skin staining and magnetic activity in the breast 2-3 weeks p

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Patients with DCIS or T1 to T3 invasive breast cancer planned for BCS and SNB study;Inclusion criteria: Patients with DCIS or T1 to T3 invasive breast cancer planned for BCS and SNB study

Exclusion criteria

Exclusion criteria: 1. Intolerance/hypersensitivity to iron or dextran compounds or Sienna XP 2. Patients with an iron overload disease 3. Patients with pacemakers or other implantable devices in the chest-wall, or prosthesis in the shoulder 4. Patient deprived of liberty or under guardianship 5. Pregnant or lactating patients 6. Intraoperative or postoperative conversion to mastectomy 7. Inability to provide informed consent;Exclusion criteria: 1. Intolerance/hypersensitivity to iron or dextran compounds or Sienna XP 2. Patients with an iron overload disease 3. Patients with pacemakers or other implantable devices in the chest-wall, or prosthesis in the shoulder 4. Patient deprived of liberty or under guardianship 5. Pregnant or lactating patients 6. Intraoperative or postoperative conversion to mastectomy 7. Inability to provide informed consent

Design outcomes

Primary

Measure	Time frame
Magnetic signal in the breast and discoloration are registered intraoperatively, 1 and 3 months after surgery. If SPIO artefacts are seen on postoperative baseline MRI conducted 3 months after the operation, the patient will be followed up 6 months postoperatively and thereafter annually with controls as stated above up to 5 years postoperatively;Magnetic signal in the breast and discoloration are registered intraoperatively, 1 and 3 months after surgery. If SPIO artefacts are seen on postoperative baseline MRI conducted 3 months after the operation, the patient will be followed up 6 months postoperatively and thereafter annually with controls as stated above up to 5 years postoperatively	—

Measure

Time frame

Magnetic signal in the breast and discoloration are registered intraoperatively, 1 and 3 months after surgery. If SPIO artefacts are seen on postoperative baseline MRI conducted 3 months after the operation, the patient will be followed up 6 months postoperatively and thereafter annually with controls as stated above up to 5 years postoperatively;Magnetic signal in the breast and discoloration are registered intraoperatively, 1 and 3 months after surgery. If SPIO artefacts are seen on postoperative baseline MRI conducted 3 months after the operation, the patient will be followed up 6 months postoperatively and thereafter annually with controls as stated above up to 5 years postoperatively

—

Secondary

Measure	Time frame
Impact of different SPIO volumes on the prevalence of skin staining and MRI artefacts;Impact of different SPIO volumes on the prevalence of skin staining and MRI artefacts	—

Countries

Sweden

Contacts

Public Contact; ;

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Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026