uPAR PET/CT for Preoperative Staging of Breast Cancer Patients
Phase II Trial: uPAR PET/CT for Preoperative Staging of Breast Cancer Patients
1 other identifier
interventional
50
1 country
1
Brief Summary
The sensitivity and specificity of uPAR PET/CT for preoperative detection of lymph node metastases in breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 breast-cancer
Started Mar 2016
Shorter than P25 for phase_2 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2016
CompletedFirst Posted
Study publicly available on registry
February 12, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2017
CompletedApril 6, 2017
April 1, 2017
12 months
February 4, 2016
April 4, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Number of axillary lymph node metastasis
1 hour
Number of distant metastases
1 hour
Other Outcomes (1)
Optimal time point for performing PET/CT following injection of 68Ga-NOTA-AE105
0-60 minutes
Study Arms (1)
uPAR PET
EXPERIMENTALOne injection of 68Ga-NOTA-AE105 followed by Positron Emission Tomography (PET/CT scan) to evaluate possible axillary lymph node metastatic lesions
Interventions
Following injection of 68Ga-NOTA-AE105 the patients will be subjected to Positron Emission Tomography PET/CT
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy
- Lactation/breast feeding
- Weight above 140 kg
- Treatment with neoadjuvant chemotherapy
- Known allergy towards the IMP
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigshospitalet, Denmarklead
- Curasight ApScollaborator
Study Sites (1)
Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Copenhagen, Copenhagen, 2100, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dorthe Skovgaard, MD PhD
Rigshospitalet, Denmark
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
February 4, 2016
First Posted
February 12, 2016
Study Start
March 1, 2016
Primary Completion
February 10, 2017
Study Completion
March 31, 2017
Last Updated
April 6, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share