breast cancer breast malignancy
Conditions
Interventions
None listed
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Women -Age >18 years -Patients who are referred to the AVL for neo-adjuvant chemotherapy treatment -Histological confirmed breast cancer (stage II/III) -Breast tumour >= 2cm
Exclusion criteria
Exclusion criteria: - 18F-FDG non-avid primary tumour (SUVmax 2 on the day of biopsy - Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters The main objective of the present study is to assess the feasibility and safety of 18F-FDG-guided biopsies using a high-resolution dedicated breast PET scanner (MAMMOCARE) in breast cancer patients. 1. Compare the F18-FDG uptake on the dedicated breast PET images with the conventional PET/CT images. 2. Analyse whether the biopsies of each patient contain enough tumor material for gene-expression and molecular subtyping analysis. 3. Check on the mammogram if the biopsy location (hydro-marker) corresponds with the location of the breast tumor. . | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary study parameters 1. Obtaining information about the duration of the 18F-FDG-guided biopsy procedures Outcome measure: The biopsy procedure starts when the patient lays on the MAMMOCARE bed and the first image acquisition starts. The biopsy procedure ends when the patient is allowed to stand up after the breast biopsies are taken. The procedure time is expressed in minutes. 2. Comparison of the gene-expression and molecular subtyping between the breast biopsies taken from the tumour region with the highest 18F-FDG uptake and the tumour border. Outcome measure: Comparing ER, PR, HER2, MIB-1 (Ki67), and AR status. 3. Measuring the radiation exposure for the physician during the biopsy procedure. Outcome measure: Dosimetry (µSv) of pocket dosimeter and ring dosimeter. | — |
Countries
Netherlands
Outcome results
None listed