uPAR PET/CT for Preoperative Staging of Breast Cancer Patients

April 4, 2017 updated by: Dorthe Skovgaard, Rigshospitalet, Denmark

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of uPAR PET/CT in identifying axillary lymph node metastases from breast cancer
Time Frame: 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.
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of axillary lymph node metastasis
Time Frame: 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.
1 hour
Number of distant metastases
Time Frame: 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.
1 hour

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optimal time point for performing PET/CT following injection of 68Ga-NOTA-AE105
Time Frame: 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
0-60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Curasight ApS

Investigators

  • Principal Investigator: Dorthe Skovgaard, MD PhD, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

February 10, 2017

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

February 4, 2016

First Submitted That Met QC Criteria

February 11, 2016

First Posted (Estimate)

February 12, 2016

Study Record Updates

Last Update Posted (Actual)

April 6, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS-2015-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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