Evaluation of a high-resolution dedicated hanging breast PET guided biopsy device for breast cancer diagnosis.

Conditions: breast cancer
breast malignancy
10006291

Registration Number: NL-OMON42670

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

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

- 18F-FDG non-avid primary tumour (SUVmax < 2.5) on conventional hanging breast PET/CT
- Breast tumour SUVmax lower than two times the SUVmax of surrounding normal breast tissue on conventional hanging breast PET/CT
- Primary tumours located within 2.5 cm distance from the chest wall (selection based on earlier performed mammography, hanging breast MRI or PET/CT).
- Active infection (breast or systemic) requiring antibiotics.
- Breast implant in affected breast
- Blood sugar level more than 10 mg/ml at time of 18F-FDG injection
- Anticoagulants usage with International Normalized Ratio (INR) > 2 on the day of biopsy
- Pregnancy

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters<br /><br><br /><br>The main objective of the present study is to assess the feasibility and safety<br /><br>of 18F-FDG-guided biopsies using a high-resolution dedicated breast PET scanner<br /><br>(MAMMOCARE) in breast cancer patients.<br /><br><br /><br>1. Compare the F18-FDG uptake on the dedicated breast PET images with the<br /><br>conventional PET/CT images.<br /><br><br /><br>2. Analyse whether the biopsies of each patient contain enough tumor material<br /><br>for gene-expression and molecular subtyping analysis.<br /><br><br /><br>3. Check on the mammogram if the biopsy location (hydro-marker) corresponds<br /><br>with the location of the breast tumor.<br /><br><br /><br>.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary study parameters<br /><br><br /><br>1. Obtaining information about the duration of the 18F-FDG-guided biopsy<br /><br>procedures<br /><br><br /><br>Outcome measure: The biopsy procedure starts when the patient lays on the<br /><br>MAMMOCARE bed and the first image acquisition starts. The biopsy procedure ends<br /><br>when the patient is allowed to stand up after the breast biopsies are taken.<br /><br>The procedure time is expressed in minutes.<br /><br><br /><br>2. Comparison of the gene-expression and molecular subtyping between the breast<br /><br>biopsies taken from the tumour region with the highest 18F-FDG uptake and the<br /><br>tumour border.<br /><br><br /><br>Outcome measure: Comparing ER, PR, HER2, MIB-1 (Ki67), and AR status.<br /><br><br /><br>3. Measuring the radiation exposure for the physician during the biopsy<br /><br>procedure.<br /><br><br /><br>Outcome measure: Dosimetry (µSv) of pocket dosimeter and ring dosimeter.</p><br>