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

April 9, 2018 updated by: Dorthe Skovgaard, Rigshospitalet, Denmark

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
evaluated on uPAR-PET/CT scan performed within 1 hour following injection of 68Ga-NOTA-AE105
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
evaluated on FDG PET/MRI performed within 1 hour following injection of 18F-FDG

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Number of true positive lymph node metastases detected by FDG-PET/MRI
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
Sensitivity for detection of true positive distant metastases by uPAR-PET/CT
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
Sensitivity for detection of true positive distant metastases by FDG-PET/MRI
evaluated on uPAR-PET/CT performed within 1 hour following injection of 18F-FDG

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Dorthe Skovgaard, Md, PhD, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

June 13, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (Estimate)

June 20, 2016

Study Record Updates

Last Update Posted (Actual)

April 11, 2018

Last Update Submitted That Met QC Criteria

April 9, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK2016-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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