Phase II trial: uPAR PET/CT and FDG PET/MRI for determining lymph node metastases in patients with bladder cancer

Phase II trial: uPAR PET/CT and FDG PET/MRI for preoperative staging of bladder cancer - Phase II trial: uPAR PET/CT and FDG PET/MRI for preoperative staging of bladder cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001026-33-DK

Enrollment

Registered

2016-04-20

Start date

2016-06-08

Completion date

Unknown

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary bladder cancer MedDRA version: 19.0 Level: LLT Classification code 10005004 Term: Bladder cancer NOS System Organ Class: 100000004864

Interventions

Product Name: 68Ga-NOTA-AE105 Product Code: 68Ga-NOTA-AE105 Pharmaceutical Form: Concentrate and solvent for solution for injection INN or Proposed INN: 68Ga-NOTA-AE105 CAS Number: NA Current Sponsor

Eligibility

Sex/Gender

All

Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35

Exclusion criteria

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 skin cancer

Design outcomes

Primary

Measure	Time frame
Main Objective: The sensitivity and specificity of 68Ga-NOTA-AE105 PET/CT and FDG PET/MR for detection of regional lymph node metastases will be tested by observer-blinded readings (two separate teams) 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. ;Secondary Objective: Number of lymph node metastases in each of the 6 lymph node regions. Detection of distant metastases. For possible detected distant metastases biopsy/follow up imaging will be used as reference test. ;Primary end point(s): Detection of lymph node metastases in each of 6 regions by the two imaging modalities: FDG PET/MR and 68Ga-NOTA-AE105 PET/CT;Timepoint(s) of evaluation of this end point: Evaluation of the primary endpoints from PET scans (FDG and 68Ga-NOTA-AE-105) performed within 1 hour post injection of FDG/68Ga-NOTA-AE105	—

Measure

Time frame

Main Objective: The sensitivity and specificity of 68Ga-NOTA-AE105 PET/CT and FDG PET/MR for detection of regional lymph node metastases will be tested by observer-blinded readings (two separate teams) 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. ;Secondary Objective: Number of lymph node metastases in each of the 6 lymph node regions. Detection of distant metastases. For possible detected distant metastases biopsy/follow up imaging will be used as reference test. ;Primary end point(s): Detection of lymph node metastases in each of 6 regions by the two imaging modalities: FDG PET/MR and 68Ga-NOTA-AE105 PET/CT;Timepoint(s) of evaluation of this end point: Evaluation of the primary endpoints from PET scans (FDG and 68Ga-NOTA-AE-105) performed within 1 hour post injection of FDG/68Ga-NOTA-AE105

—

Secondary

Measure	Time frame
Secondary end point(s): Number of lymph node metastases in each of 6 regions Distant metastases;Timepoint(s) of evaluation of this end point: Evaluation of the secondary endpoints from PET scans (FDG and 68Ga-NOTA-AE-105) performed within 1 hour post injection of FDG/68Ga-NOTA-AE105	—

Countries

Denmark

Contacts

Public ContactDorthe Skovgaard

Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET

dskovgaard@dadlnet.dk004561274706

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026