Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

uPAR PET/CT and FDG PET/MRI for Preoperative Staging of Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02805608
Recruitment Status : Unknown
Verified April 2018 by Dorthe Skovgaard, Rigshospitalet, Denmark.
Recruitment status was:  Active, not recruiting
First Posted : June 20, 2016
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Dorthe Skovgaard, Rigshospitalet, Denmark

Brief 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

Condition or disease Intervention/treatment Phase
Urinary Bladder Neoplasms Drug: Injection of 68Ga-NOTA-AE105 Drug: Injection of 18F-FDG Device: Positron Emission Tomography and CT Device: Positron Emission Tomography and MRI Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase II Trial: uPAR PET/CT and FDG PET/MRI for Preoperative Staging of Bladder Cancer
Study Start Date : September 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: 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.
Drug: Injection of 68Ga-NOTA-AE105
One injection intravenously of 68Ga-NOTA-AE105

Drug: Injection of 18F-FDG
One injection intravenously of 18F-FDG

Device: Positron Emission Tomography and CT
Following of injection of 68Ga-NOTA-AE105 the patients will be PET/CT scanned starting 20 minutes post injection

Device: Positron Emission Tomography and MRI
Following injection of 18F-FDG the patients will be PET/MRI scanned starting 60 minutes post injection




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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 ]
    Number of true positive lymph node metastases detected by uPAR-PET/CT

  2. FDG PET/MRI: Number of lymph node metastases [ Time Frame: evaluated on FDG PET/MRI performed within 1 hour following injection of 18F-FDG ]
    Number of true positive lymph node metastases detected by FDG-PET/MRI

  3. 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 ]
    Sensitivity for detection of true positive distant metastases by uPAR-PET/CT

  4. 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 ]
    Sensitivity for detection of true positive distant metastases by FDG-PET/MRI



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy-verified urinary bladder cancer
  • The participants must be capable of understanding and giving full informed written consent age above 18 years

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805608


Locations
Layout table for location information
Denmark
Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Layout table for investigator information
Principal Investigator: Dorthe Skovgaard, Md, PhD Rigshospitalet, Denmark
Layout table for additonal information
Responsible Party: Dorthe Skovgaard, MD, Phd, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02805608    
Other Study ID Numbers: AK2016-1
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action