Breast cancer, borstkanker Results are also applicable to melanoma, prostate cancer. Resultaten zijn ook toepasbaar op melanoom en prostaatkanker.
Conditions
Interventions
A low dose peritumoral injection of Sienna+ (2x 0.5 mL), with a total dose of approximately 1.1 mg iron.
Sponsors
University of Twente, Enschede, the Netherlands
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 5.Patients having a pacemaker implanted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The proportion of sentinel nodes correctly detected with the magnetic method 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 „³ sensitivity; 4. The number and percentage of sentinel lymph nodes correctly diagnosed to be non-metastatic using ex vivo MRI specificity. | — |
Secondary
| Measure | Time frame |
|---|---|
| 5. The iron content in the dissected sentinel lymph nodes (average, minimum and maximum) in relation to the image quality; 6. The image parameters indicative for the presence of sentinel lymph node metastases; 7. The requirements in detection depth and minimally detectable mg iron per node for future magnetometers; 8. The usability of a dose of 1.1 mg iron in 1 ml injected volume for the proposed study. | — |
Contacts
Public ContactM. Heijblom
MIRA Institute for Biomedical Technology and Technical Medicine University of Twente P.O. Box 217
Outcome results
None listed