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

NCT ID: NCT02805608

Last Updated: 2018-04-11

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-01-31

Brief Summary

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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

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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

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Urinary Bladder Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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.

Group Type EXPERIMENTAL

Injection of 68Ga-NOTA-AE105

Intervention Type DRUG

One injection intravenously of 68Ga-NOTA-AE105

Injection of 18F-FDG

Intervention Type DRUG

One injection intravenously of 18F-FDG

Positron Emission Tomography and CT

Intervention Type DEVICE

Following of injection of 68Ga-NOTA-AE105 the patients will be PET/CT scanned starting 20 minutes post injection

Positron Emission Tomography and MRI

Intervention Type DEVICE

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

Intervention Type DRUG

Injection of 18F-FDG

One injection intravenously of 18F-FDG

Intervention Type DRUG

Positron Emission Tomography and CT

Following of injection of 68Ga-NOTA-AE105 the patients will be PET/CT scanned starting 20 minutes post injection

Intervention Type DEVICE

Positron Emission Tomography and MRI

Following injection of 18F-FDG the patients will be PET/MRI scanned starting 60 minutes post injection

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Dorthe Skovgaard

MD, Phd

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Denmark

Other Identifiers

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AK2016-1

Identifier Type: -

Identifier Source: org_study_id

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