Super Paramagnetic Iron Oxide (SPIO) tracer for sentinel node biopsy (SNB) in breast cancer.

The routine use of super paramagnetic iron oxide nanoparticles as the sole method for sentinel node biopsy in patients with breast cancer. The MONOS study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14097881

Enrollment

254

Registered

2016-05-31

Start date

2014-09-01

Completion date

Unknown

Last updated

2018-01-15

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

Conditions

Breast cancer Cancer

Interventions

Patients are recruited from Akademiska University Hospital, Uppsala, Sweden and Västmanlands County Hospital, Västerås, Sweden. Patients recruited at Uppsala University Hospital will be enrolled in th

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults (>18 yrs of age) 2. Mentally capable of processing information. 3. Patients scheduled for a SNB

Exclusion criteria

Exclusion criteria: 1. Patients with pacemaker or other implantable metallic devices in the chest 2. Patients with allergy or intolerance to iron and dextran compounds 3. Patients with hemochromatosis 4. Pregnant patients 5. Lactating patients

Design outcomes

Primary

Measure	Time frame
1. Intraoperative detection rate per case defined as the number of successful cases per method divided by the total amount of cases performed in the respective arm (Sienna+ and Tc99). 2. Detection rate per case, specific for patients injected with Sienna+ in the preoperative outpatient setting and not perioperatively. 3. Intraoperative detection rate per node defined as the number of nodes retrieved successfully per method divided by the total amount of nodes retrieved in the respective arm (Sienna+ and Tc99).	—

Measure

Time frame

1. Intraoperative detection rate per case defined as the number of successful cases per method divided by the total amount of cases performed in the respective arm (Sienna+ and Tc99). 2. Detection rate per case, specific for patients injected with Sienna+ in the preoperative outpatient setting and not perioperatively. 3. Intraoperative detection rate per node defined as the number of nodes retrieved successfully per method divided by the total amount of nodes retrieved in the respective arm (Sienna+ and Tc99).

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Secondary

Measure	Time frame
1. Size and fading of staining (intervention arm only) in the postoperative period (at 3, 6, 9,12,15, 18 months) . The size of staining will be measured in maximum dimensions and the intensity of the staining will be registered as to if it is persistent or paler. 2. Problems experienced by patients due to remaining skin staining, assessed with Likert scale from 0 (not a cosmetic problem at all) to 5 (very ugly)) at 15 and 18 months postoperative. 3. Costs per method per patient 4. Primary benefit cost analysis	—

Measure

Time frame

1. Size and fading of staining (intervention arm only) in the postoperative period (at 3, 6, 9,12,15, 18 months) . The size of staining will be measured in maximum dimensions and the intensity of the staining will be registered as to if it is persistent or paler. 2. Problems experienced by patients due to remaining skin staining, assessed with Likert scale from 0 (not a cosmetic problem at all) to 5 (very ugly)) at 15 and 18 months postoperative. 3. Costs per method per patient 4. Primary benefit cost analysis

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Countries

Sweden

Outcome results

None listed

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