Low dose SPIO injection for a complete magnetic, radiation-free, procedure for sentinel lymph node detection and metastases evaluation.

Low dose SPIO injection for a complete magnetic, radiation-free, procedure for sentinel lymph node detection and metastases evaluation. - Low dose magnetic sentinel lymph node detection and evaluation

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56058

Enrollment

Registered

2014-12-16

Start date

2016-10-28

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

breast cancer breast carcinoma

Interventions

Optional in vivo MRI. and ex vivo MRI of the lymph nodes

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Adult patients with breast cancer scheduled for a SLNB procedure or axillary dissection and have at maximum clinically (palpation and ultrasound) N+, and that gave informed consent for participation to the study.

Exclusion criteria

Exclusion criteria: 1.Patients incapable of giving informed consent for participation to the study; 2.Intolerance / hypersensitivity to iron or dextran compounds; 3.Pregnant or lactating pratients 4.Patients having a pacemaker implanted. Exclusion criteria as long as the post-surgery MRI is obligated Patients scheduled for a lumpectomy and who are not eligible for MRI according to the MRI exclusion criteria of MST.

Design outcomes

Primary

Measure	Time frame
1. The proportion of sentinel nodes correctly detected with the magnetic technique (magnetometer) 2. The proportion of patients in which the sentinel lymph nodes could successfully be detected (detection rate) using the magnetometer. 3. The number and percentage of sentinel lymph nodes correctly diagnosed to be metastatic using ex vivo MRI. 4. The number and percentage of sentinel lymph nodes correctly diagnosed to be non-metastatic using ex vivo MRI. 5. The uptake of SPIO particles in normal breast tissue versus tumor tissue. 6. The number and percentage of sentinel lymph nodes correctly diagnosed to be metastatic using in vivo MRI. 7. The number and percentage of sentinel lymph nodes correctly diagnosed to be non-metastatic using in vivo MRI.	—

Measure

Time frame

1. The proportion of sentinel nodes correctly detected with the magnetic technique (magnetometer) 2. The proportion of patients in which the sentinel lymph nodes could successfully be detected (detection rate) using the magnetometer. 3. The number and percentage of sentinel lymph nodes correctly diagnosed to be metastatic using ex vivo MRI. 4. The number and percentage of sentinel lymph nodes correctly diagnosed to be non-metastatic using ex vivo MRI. 5. The uptake of SPIO particles in normal breast tissue versus tumor tissue. 6. The number and percentage of sentinel lymph nodes correctly diagnosed to be metastatic using in vivo MRI. 7. The number and percentage of sentinel lymph nodes correctly diagnosed to be non-metastatic using in vivo MRI.

—

Secondary

Measure	Time frame
8. The iron content in the dissected lymph nodes (average, minimum and maximum) in relation to the image quality; 9. The image parameters indicative for the presence of lymph node metastases; 10. The requirements in detection depth and minimally detectable mg iron per node for future magnetometers.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)