search
Back to results

uPAR PET/CT for Preoperative Staging of Breast Cancer Patients

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
68Ga-NOTA-AE105
Positron Emission Tomography PET/CT
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

uPAR PET

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 4, 2016
Last Updated
April 4, 2017
Sponsor
Rigshospitalet, Denmark
Collaborators
Curasight ApS
search

1. Study Identification

Unique Protocol Identification Number
NCT02681640
Brief Title
uPAR PET/CT for Preoperative Staging of Breast Cancer Patients
Official Title
Phase II Trial: uPAR PET/CT for Preoperative Staging of Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
February 10, 2017 (Actual)
Study Completion Date
March 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Curasight ApS

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
uPAR PET
Arm Type
Experimental
Arm Description
One injection of 68Ga-NOTA-AE105 followed by Positron Emission Tomography (PET/CT scan) to evaluate possible axillary lymph node metastatic lesions
Intervention Type
Other
Intervention Name(s)
68Ga-NOTA-AE105
Intervention Description
One injection of 68Ga-NOTA-AE105
Intervention Type
Device
Intervention Name(s)
Positron Emission Tomography PET/CT
Intervention Description
Following injection of 68Ga-NOTA-AE105 the patients will be subjected to Positron Emission Tomography PET/CT
Primary Outcome Measure Information:
Title
Sensitivity and specificity of uPAR PET/CT in identifying axillary lymph node metastases from breast cancer
Description
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.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Number of axillary lymph node metastasis
Description
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.
Time Frame
1 hour
Title
Number of distant metastases
Description
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.
Time Frame
1 hour
Other Pre-specified Outcome Measures:
Title
Optimal time point for performing PET/CT following injection of 68Ga-NOTA-AE105
Description
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
Time Frame
0-60 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorthe Skovgaard, MD PhD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

uPAR PET/CT for Preoperative Staging of Breast Cancer Patients

We'll reach out to this number within 24 hrs