Urinary Bladder NeoplasmsPhase 2NCT02805608
uPAR PET/CT and FDG PET/MRI for Preoperative Staging of Bladder Cancer
A Phase 2 study testing Injection of 68Ga-NOTA-AE105, Injection of 18F-FDG and Positron Emission Tomography and CT in people with Urinary Bladder Neoplasms, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The sensitivity and specificity of uPAR PET/CT with the radioligand 68GaNOTA-AE105 and FDG PET/MRI for preoperative detection of regional lymph node metastases in urinary bladder cancer Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Urinary Bladder Neoplasms
- What is being tested?
- Injection of 68Ga-NOTA-AE105, Injection of 18F-FDG and Positron Emission Tomography and CT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2016to Jan 2019
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-verified urinary bladder cancer
- The participants must be capable of understanding and giving full informed written consent age above 18 years
Who cannot join
- Pregnancy
- Lactation/breast feeding
- Age above 85 years old
- Weight above 140 kg
- Treatment with neoadjuvant chemotherapy
- Known allergy towards 68Ga-NOTA-AE105
- Other malignant disease within last 5 years, except for non-melanoma
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Copenhagen, 2100
About this study
Official title: Phase II Trial: uPAR PET/CT and FDG PET/MRI for Preoperative Staging of Bladder Cancer
The sensitivity and specificity of uPAR PET/CT with the radioligand 68GaNOTA-AE105 and FDG PET/MRI for preoperative detection of regional lymph node metastases in urinary bladder cancer
Read the detailed description
The sensitivity and specificity of 68Ga-NOTA-AE105 PET/CT and FDG PET/MRI for detection of regional lymph node metastases will be tested by observer-blinded readings and compared to diagnostic performance of conventional preoperative procedure. The reference test will be histopathology of lymph nodes obtained by operative lymph node dissection based on 6 regions. The suspected lymph nodes will be assigned to 6 regions based on the images. During the following operation the lymph nodes will be removed and analysed in each of these regions.
- Conditions
- Urinary Bladder Neoplasms
- Being tested
- Injection of 68Ga-NOTA-AE105, Injection of 18F-FDG, Positron Emission Tomography and CT, Positron Emission Tomography and MRI
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of 68Ga-NOTA-AE105Drug
One injection intravenously of 68Ga-NOTA-AE105
Injection of 18F-FDGDrug
One injection intravenously of 18F-FDG
Positron Emission Tomography and CTDevice
Following of injection of 68Ga-NOTA-AE105 the patients will be PET/CT scanned starting 20 minutes post injection
Positron Emission Tomography and MRIDevice
Following injection of 18F-FDG the patients will be PET/MRI scanned starting 60 minutes post injection
| Study group | Role | What they receive |
|---|---|---|
| uPAR PET/CT and FDG PET/MR | Experimental | One injection of 68Ga-NOTA-AE105 followed by PET/CT and on a separate day one injection of 18F-FDG followed by PET/MRI. Both scans will be evaluated for possible regional lymph node metastases. Receives: Drug: Injection of 68Ga-NOTA-AE105; Drug: Injection of 18F-FDG; Device: Positron Emission Tomography and CT; Device: Positron Emission Tomography and MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
uPAR PET/CT: regional lymph node metastases
Sensitivity of uPAR-PET/CT detection of regional lymph node metastases by 68Ga-NOTA-AE105 PET/CT
Measured: evaluated on uPAR-PET/CT scan performed within 1 hour following injection of 68Ga-NOTA-AE105
FDG PET/MRI: regional lymph node metastases
Sensitivity of FDG-PET/MRI for detection of regional lymph node metastases
Measured: evaluated on FDG PET/MRI performed within 1 hour following injection of 18F-FDG
Secondary outcomes (4)
uPAR PET/CT: Number of lymph node metastases
Number of true positive lymph node metastases detected by uPAR-PET/CT
Measured: evaluated on uPAR-PET/CT performed within 1 hour following injection of 68Ga-NOTA-AE105
FDG PET/MRI: Number of lymph node metastases
Number of true positive lymph node metastases detected by FDG-PET/MRI
Measured: evaluated on FDG PET/MRI performed within 1 hour following injection of 18F-FDG
uPAR PET/CT: sensitivity for detection of distant metastases
Sensitivity for detection of true positive distant metastases by uPAR-PET/CT
Measured: evaluated on uPAR-PET/CT performed within 1 hour following injection of 68Ga-NOTA-AE105
FDG PET/MRI: sensitivity for detection of distant metastases
Sensitivity for detection of true positive distant metastases by FDG-PET/MRI
Measured: evaluated on uPAR-PET/CT performed within 1 hour following injection of 18F-FDG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startSep 2016
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder NeoplasmsStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- 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
- NCT02805608
- Sponsor's protocol ID
- AK2016-1
- Status last verified
- Apr 2018
- First submitted
- 13 Jun 2016
- Last updated
- 11 Apr 2018
- 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 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial: uPAR PET/CT and FDG PET/MRI for Preoperative Staging of Bladder Cancer
- ClinicalTrials.gov ID
- NCT02805608
- Acronym / sponsor ID
- AK2016-1
- Conditions
- Urinary Bladder Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 20 Jun 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 with the radioligand 68GaNOTA-AE105 and FDG PET/MRI for preoperative detection of regional lymph node metastases in urinary bladder cancer
Detailed description
The sensitivity and specificity of 68Ga-NOTA-AE105 PET/CT and FDG PET/MRI for detection of regional lymph node metastases will be tested by observer-blinded readings and compared to diagnostic performance of conventional preoperative procedure. The reference test will be histopathology of lymph nodes obtained by operative lymph node dissection based on 6 regions. The suspected lymph nodes will be assigned to 6 regions based on the images. During the following operation the lymph nodes will be removed and analysed in each of these regions.
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/CT and FDG PET/MR | Experimental | Drug: Injection of 68Ga-NOTA-AE105, Drug: Injection of 18F-FDG, Device: Positron Emission Tomography and CT, Device: Positron Emission Tomography and MRIOne injection of 68Ga-NOTA-AE105 followed by PET/CT and on a separate day one injection of 18F-FDG followed by PET/MRI. Both scans will be evaluated for possible regional lymph node metastases. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Biopsy-verified urinary bladder cancer
- The participants must be capable of understanding and giving full informed written consent age above 18 years
Key exclusion criteria (7 listed)
- Pregnancy
- Lactation/breast feeding
- Age above 85 years old
- Weight above 140 kg
- Treatment with neoadjuvant chemotherapy
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 |
|---|---|---|
| Injection of 68Ga-NOTA-AE105One injection intravenously of 68Ga-NOTA-AE105 | Drug | uPAR PET/CT and FDG PET/MR |
| Injection of 18F-FDGOne injection intravenously of 18F-FDG | Drug | uPAR PET/CT and FDG PET/MR |
| Positron Emission Tomography and CTFollowing of injection of 68Ga-NOTA-AE105 the patients will be PET/CT scanned starting 20 minutes post injection | Device | uPAR PET/CT and FDG PET/MR |
| Positron Emission Tomography and MRIFollowing injection of 18F-FDG the patients will be PET/MRI scanned starting 60 minutes post injection | Device | uPAR PET/CT and FDG PET/MR |
Primary outcome
uPAR PET/CT: regional lymph node metastases
Time frame: evaluated on uPAR-PET/CT scan performed within 1 hour following injection of 68Ga-NOTA-AE105
Sensitivity of uPAR-PET/CT detection of regional lymph node metastases by 68Ga-NOTA-AE105 PET/CT
FDG PET/MRI: regional lymph node metastases
Time frame: evaluated on FDG PET/MRI performed within 1 hour following injection of 18F-FDG
Sensitivity of FDG-PET/MRI for detection of regional lymph node metastases
4 secondary outcomes
uPAR PET/CT: Number of lymph node metastases
Time frame: evaluated on uPAR-PET/CT performed within 1 hour following injection of 68Ga-NOTA-AE105
FDG PET/MRI: Number of lymph node metastases
Time frame: evaluated on FDG PET/MRI performed within 1 hour following injection of 18F-FDG
uPAR PET/CT: sensitivity for detection of distant metastases
Time frame: evaluated on uPAR-PET/CT performed within 1 hour following injection of 68Ga-NOTA-AE105
FDG PET/MRI: sensitivity for detection of distant metastases
Time frame: evaluated on uPAR-PET/CT performed within 1 hour following injection of 18F-FDG
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- 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 Injection of 68Ga-NOTA-AE105, Injection of 18F-FDG and Positron Emission Tomography and CT in people with Urinary Bladder Neoplasms, 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 11 Apr 2018. 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?
Results are not available in the source record.
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?
uPAR PET/CT: regional lymph node metastases (time frame: evaluated on uPAR-PET/CT scan performed within 1 hour following injection of 68Ga-NOTA-AE105). The study lists 2 primary outcomes in all. 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 11 Apr 2018.