uPAR PET/CT for Preoperative Staging of Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

Phase II Trial: uPAR PET/CT for Preoperative Staging of Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02681640
• Other study ID #: CS-2015-1
• Status: Completed
• Phase: Phase 2
• First received: February 4, 2016
• Last updated: April 4, 2017
• Start date: March 2016
• Est. completion date: March 31, 2017

Study information

• Verified date: April 2017
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 31, 2017
• Est. primary completion date: February 10, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• 68Ga-NOTA-AE105
One injection of 68Ga-NOTA-AE105

Device:
• Positron Emission Tomography PET/CT
Following injection of 68Ga-NOTA-AE105 the patients will be subjected to Positron Emission Tomography PET/CT

Locations

Country	Name	City	State
Denmark	Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Curasight ApS

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Optimal time point for performing PET/CT following injection of 68Ga-NOTA-AE105	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	0-60 minutes
Primary	Sensitivity and specificity of uPAR PET/CT in identifying axillary lymph node metastases from breast cancer	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.	1 hour
Secondary	Number of axillary lymph node metastasis	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.	1 hour
Secondary	Number of distant metastases	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.	1 hour