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

Rigshospitalet

Status and phase: Unknown; Phase 2

Conditions: Urinary Bladder Neoplasms

Treatments: Device: Positron Emission Tomography and MRI; Device: Positron Emission Tomography and CT; Drug: Injection of 18F-FDG; Drug: Injection of 68Ga-NOTA-AE105

Study type: Interventional

Funder types: Other

Identifiers

NCT02805608

AK2016-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

uPAR PET/CT and FDG PET/MR

Experimental group

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.

Treatment:

Device: Positron Emission Tomography and CT

Drug: Injection of 18F-FDG

Drug: Injection of 68Ga-NOTA-AE105

Device: Positron Emission Tomography and MRI