A complete magnetic radiation free procedure for sentinel lymph node localization

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28812

Enrollment

Registered

2014-10-22

Start date

2015-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Sentinel Lymph Node Biopsy in breast cancer and melanoma patients. Outcomes are potentially of benefit for more solid cancer patients.

Interventions

Two peritumoral injection of SPIO (SIENNA+), 1 mg in 1 mL following the injection of TC99m and lymphoscintigraphy. The intraoperative detection of the SPIO accumulation in SLNS by a handheld magneto

Eligibility

Inclusion criteria

Inclusion criteria: Adult, clinically (palpation and ultrasound) node negative, patients that are diagnosed with invasive breast cancer or high grade ductal carcinoma in situ and that are scheduled for a two-day SLNB procedure 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.Patients that have received neoadjuvant chemotherapy in the period of 5 years prior to this study. 4.Pregnant or lactating patients

Design outcomes

Primary

Measure	Time frame
1. The proportion of sentinel nodes correctly detected with the magnetic technique (magnetometer) as compared to the combined technique (visually and/or using the gammaprobe). 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.	—

Measure

Time frame

1. The proportion of sentinel nodes correctly detected with the magnetic technique (magnetometer) as compared to the combined technique (visually and/or using the gammaprobe). 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.

—

Secondary

Measure	Time frame
5. The iron content in the dissected lymph nodes (average, minimum and maximum) in relation to the image quality; 6. The image parameters indicative for the presence of lymph node metastases; 7. The requirements in detection depth and minimally detectable mg iron per node for future magnetometers.	—

Contacts

Public ContactM. Heijblom

MIRA Institute for Biomedical Technology and Technical Medicine University of Twente P.O. Box 217

m.heijblom@utwente.nl+31 (0)53 4893877

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)