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

Primary Purpose

Urinary Bladder Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Injection of 68Ga-NOTA-AE105
Injection of 18F-FDG
Positron Emission Tomography and CT
Positron Emission Tomography and MRI
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urinary Bladder Neoplasms

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

uPAR PET/CT and FDG PET/MR

Arm Description

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.

Outcomes

Primary Outcome Measures

uPAR PET/CT: regional lymph node metastases
Sensitivity of uPAR-PET/CT detection of regional lymph node metastases by 68Ga-NOTA-AE105 PET/CT
FDG PET/MRI: regional lymph node metastases
Sensitivity of FDG-PET/MRI for detection of regional lymph node metastases

Secondary Outcome Measures

uPAR PET/CT: Number of lymph node metastases
Number of true positive lymph node metastases detected by uPAR-PET/CT
FDG PET/MRI: Number of lymph node metastases
Number of true positive lymph node metastases detected by FDG-PET/MRI
uPAR PET/CT: sensitivity for detection of distant metastases
Sensitivity for detection of true positive distant metastases by uPAR-PET/CT
FDG PET/MRI: sensitivity for detection of distant metastases
Sensitivity for detection of true positive distant metastases by FDG-PET/MRI

Full Information

First Posted
June 13, 2016
Last Updated
April 9, 2018
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02805608
Brief Title
uPAR PET/CT and FDG PET/MRI for Preoperative Staging of Bladder Cancer
Official Title
Phase II Trial: uPAR PET/CT and FDG PET/MRI for Preoperative Staging of Bladder Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Neoplasms

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
uPAR PET/CT and FDG PET/MR
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Injection of 68Ga-NOTA-AE105
Intervention Description
One injection intravenously of 68Ga-NOTA-AE105
Intervention Type
Drug
Intervention Name(s)
Injection of 18F-FDG
Intervention Description
One injection intravenously of 18F-FDG
Intervention Type
Device
Intervention Name(s)
Positron Emission Tomography and CT
Intervention Description
Following of injection of 68Ga-NOTA-AE105 the patients will be PET/CT scanned starting 20 minutes post injection
Intervention Type
Device
Intervention Name(s)
Positron Emission Tomography and MRI
Intervention Description
Following injection of 18F-FDG the patients will be PET/MRI scanned starting 60 minutes post injection
Primary Outcome Measure Information:
Title
uPAR PET/CT: regional lymph node metastases
Description
Sensitivity of uPAR-PET/CT detection of regional lymph node metastases by 68Ga-NOTA-AE105 PET/CT
Time Frame
evaluated on uPAR-PET/CT scan performed within 1 hour following injection of 68Ga-NOTA-AE105
Title
FDG PET/MRI: regional lymph node metastases
Description
Sensitivity of FDG-PET/MRI for detection of regional lymph node metastases
Time Frame
evaluated on FDG PET/MRI performed within 1 hour following injection of 18F-FDG
Secondary Outcome Measure Information:
Title
uPAR PET/CT: Number of lymph node metastases
Description
Number of true positive lymph node metastases detected by uPAR-PET/CT
Time Frame
evaluated on uPAR-PET/CT performed within 1 hour following injection of 68Ga-NOTA-AE105
Title
FDG PET/MRI: Number of lymph node metastases
Description
Number of true positive lymph node metastases detected by FDG-PET/MRI
Time Frame
evaluated on FDG PET/MRI performed within 1 hour following injection of 18F-FDG
Title
uPAR PET/CT: sensitivity for detection of distant metastases
Description
Sensitivity for detection of true positive distant metastases by uPAR-PET/CT
Time Frame
evaluated on uPAR-PET/CT performed within 1 hour following injection of 68Ga-NOTA-AE105
Title
FDG PET/MRI: sensitivity for detection of distant metastases
Description
Sensitivity for detection of true positive distant metastases by FDG-PET/MRI
Time Frame
evaluated on uPAR-PET/CT performed within 1 hour following injection of 18F-FDG

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorthe Skovgaard, Md, PhD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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

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