uPAR PET/CT for Preoperative Staging of Breast Cancer Patients

Rigshospitalet

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Other: 68Ga-NOTA-AE105; Device: Positron Emission Tomography PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT02681640

CS-2015-1

Details and patient eligibility

About

The sensitivity and specificity of uPAR PET/CT for preoperative detection of lymph node metastases in breast cancer.

Full 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.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

uPAR PET

Experimental group

Description:

One injection of 68Ga-NOTA-AE105 followed by Positron Emission Tomography (PET/CT scan) to evaluate possible axillary lymph node metastatic lesions

Treatment:

Device: Positron Emission Tomography PET/CT

Other: 68Ga-NOTA-AE105