uPAR PET/CT for Preoperative Staging of Breast Cancer Patients

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Other: 68Ga-NOTA-AE105; Device: Positron Emission Tomography PET/CT

• Registration Number: NCT02681640
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study First Submitted: 2016-02-04
• Study First Submitted QC: 2016-02-11
• Study First Posted: 2016-02-12
• Study Start: 2016-03
• Primary Completion: 2017-02-10
• Study Completion: 2017-03-31
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-04
• Last Update Posted: 2017-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet; 🇩🇰 Copenhagen, Denmark