Breast CancerPhase 2NCT02681640
uPAR PET/CT for Preoperative Staging of Breast Cancer Patients
A Phase 2 study testing 68Ga-NOTA-AE105 and Positron Emission Tomography PET/CT in people with Breast Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The sensitivity and specificity of uPAR PET/CT for preoperative detection of lymph node metastases in breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 68Ga-NOTA-AE105 and Positron Emission Tomography PET/CT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2016to 31 Mar 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Lactation/breast feeding
- Weight above 140 kg
- Treatment with neoadjuvant chemotherapy
- Known allergy towards the IMP
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Copenhagen, Copenhagen, 2100
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- 68Ga-NOTA-AE105, Positron Emission Tomography PET/CT
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NOTA-AE105Other
One injection of 68Ga-NOTA-AE105
Positron Emission Tomography PET/CTDevice
Following injection of 68Ga-NOTA-AE105 the patients will be subjected to Positron Emission Tomography PET/CT
| Study group | Role | What they receive |
|---|---|---|
| uPAR PET | Experimental | One injection of 68Ga-NOTA-AE105 followed by Positron Emission Tomography (PET/CT scan) to evaluate possible axillary lymph node metastatic lesions Receives: Other: 68Ga-NOTA-AE105; Device: Positron Emission Tomography PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (2)
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.
Measured: 1 hour
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startMar 2016
- Primary completion10 Feb 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Curasight ApS
- Responsible party
- Principal investigator, Dorthe Skovgaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Dorthe Skovgaard, MD PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681640
- Sponsor's protocol ID
- CS-2015-1
- Status last verified
- Apr 2017
- First submitted
- 4 Feb 2016
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial: uPAR PET/CT for Preoperative Staging of Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02681640
- Acronym / sponsor ID
- CS-2015-1
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Curasight ApS
- Study start
- Mar 2016
- Primary completion
- 10 Feb 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 12 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| uPAR PET | Experimental | Other: 68Ga-NOTA-AE105, Device: Positron Emission Tomography PET/CTOne injection of 68Ga-NOTA-AE105 followed by Positron Emission Tomography (PET/CT scan) to evaluate possible axillary lymph node metastatic lesions |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Pregnancy
- Lactation/breast feeding
- Weight above 140 kg
- Treatment with neoadjuvant chemotherapy
- Known allergy towards the IMP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-NOTA-AE105One injection of 68Ga-NOTA-AE105 | Other | uPAR PET |
| Positron Emission Tomography PET/CTFollowing injection of 68Ga-NOTA-AE105 the patients will be subjected to Positron Emission Tomography PET/CT | Device | uPAR PET |
Primary outcome
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.
2 secondary outcomes
Number of axillary lymph node metastasis
Time frame: 1 hour
Number of distant metastases
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dorthe Skovgaard, MD PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 68Ga-NOTA-AE105 and Positron Emission Tomography PET/CT in people with Breast Cancer, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of uPAR PET/CT in identifying axillary lymph node metastases from breast cancer (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2017.