Breast Cancer
Conditions
Brief summary
The sensitivity and specificity of uPAR PET/CT for preoperative detection of lymph node metastases in breast cancer.
Detailed description
The sensitivity and specificity of uPAR PET/CT for detection of lymph node metastases will be tested by observer-blinded readings (two separate teams) and compared to diagnostic performance of conventional preoperative diagnostic workup procedures. The reference test will be histopathology of lymph nodes obtained by operative lymph node dissection (SN/ALND). Primary end point dichotomized: +/- lymph node metastases in ipsilateral axilla.
Interventions
OTHER68Ga-NOTA-AE105
One injection of 68Ga-NOTA-AE105
DEVICEPositron Emission Tomography PET/CT
Following injection of 68Ga-NOTA-AE105 the patients will be subjected to Positron Emission Tomography PET/CT
Sponsors
Curasight ApS
Rigshospitalet, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Biopsy-verified breast cancer * Primary tumor more than 2 cm (ultrasound or clinically) * The participants must be capable of understanding and giving full informed written consent
Exclusion criteria
* Pregnancy * Lactation/breast feeding * Weight above 140 kg * Treatment with neoadjuvant chemotherapy * Known allergy towards the IMP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of uPAR PET/CT in identifying axillary lymph node metastases from breast cancer | 1 hour | Two separate teams of certified specialists (1 radiology and 1 nuclear medicine) will based on uPAR-PET/CT assess the presence of metastases in axillary lymph nodes (spread/no spread). Lymph Node sampling and histopathology determine true positives and true negatives. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of axillary lymph node metastasis | 1 hour | Two separate teams of certified specialists (1 radiology and 1 nuclear medicine) will based on uPAR-PET/CT assess the number of metastases in axillary lymph nodes. Lymph node sampling and histopathology determine true positives and true negatives. |
| Number of distant metastases | 1 hour | Two separate teams of certified specialists (1 radiology and 1 nuclear medicine) will based on uPAR-PET/CT assess the number of distant metastases. Biopsy/follow up imaging will be used as reference. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Optimal time point for performing PET/CT following injection of 68Ga-NOTA-AE105 | 0-60 minutes | The first 5 patients will be subjected to 60 minutes of dynamic PET imaging covering the breast tumor area, starting at the time of injection. The PET scan will be divided into 12 time frames of each 5 minutes. The time frame with the best visual tumor to background contrast, will be designated as the optimal time point p.i. for uPAR-PET/CT |
Countries
Denmark
Outcome results
None listed