uPAR PET/CT and FDG PET/MRI for Preoperative Staging of Bladder Cancer
NCT ID: NCT02805608
Last Updated: 2018-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2016-09-30
2019-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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uPAR PET/CT and FDG PET/MR
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.
Injection of 68Ga-NOTA-AE105
One injection intravenously of 68Ga-NOTA-AE105
Injection of 18F-FDG
One injection intravenously of 18F-FDG
Positron Emission Tomography and CT
Following of injection of 68Ga-NOTA-AE105 the patients will be PET/CT scanned starting 20 minutes post injection
Positron Emission Tomography and MRI
Following injection of 18F-FDG the patients will be PET/MRI scanned starting 60 minutes post injection
Interventions
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Injection of 68Ga-NOTA-AE105
One injection intravenously of 68Ga-NOTA-AE105
Injection of 18F-FDG
One injection intravenously of 18F-FDG
Positron Emission Tomography and CT
Following of injection of 68Ga-NOTA-AE105 the patients will be PET/CT scanned starting 20 minutes post injection
Positron Emission Tomography and MRI
Following injection of 18F-FDG the patients will be PET/MRI scanned starting 60 minutes post injection
Eligibility Criteria
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Inclusion Criteria
* The participants must be capable of understanding and giving full informed written consent age above 18 years
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Dorthe Skovgaard
MD, Phd
Principal Investigators
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Dorthe Skovgaard, Md, PhD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Copenhagen, , Denmark
Countries
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Other Identifiers
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AK2016-1
Identifier Type: -
Identifier Source: org_study_id
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