NCT02805608

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 20, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

April 11, 2018

Status Verified

April 1, 2018

Enrollment Period

2.3 years

First QC Date

June 13, 2016

Last Update Submit

April 9, 2018

Conditions

Urinary Bladder Neoplasms

Outcome Measures

Primary Outcomes (2)

  • uPAR PET/CT: regional lymph node metastases

    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

    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 Outcomes (4)

  • uPAR PET/CT: Number of lymph node metastases

    evaluated on uPAR-PET/CT performed within 1 hour following injection of 68Ga-NOTA-AE105

  • FDG PET/MRI: Number of lymph node metastases

    evaluated on FDG PET/MRI performed within 1 hour following injection of 18F-FDG

  • uPAR PET/CT: sensitivity for detection of distant metastases

    evaluated on uPAR-PET/CT performed within 1 hour following injection of 68Ga-NOTA-AE105

  • FDG PET/MRI: sensitivity for detection of distant metastases

    evaluated on uPAR-PET/CT performed within 1 hour following injection of 18F-FDG

Study Arms (1)

uPAR PET/CT and FDG PET/MR

EXPERIMENTAL

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-AE105Drug: Injection of 18F-FDGDevice: Positron Emission Tomography and CTDevice: Positron Emission Tomography and MRI

Interventions

Injection of 68Ga-NOTA-AE105DRUG

One injection intravenously of 68Ga-NOTA-AE105

uPAR PET/CT and FDG PET/MR
Injection of 18F-FDGDRUG

One injection intravenously of 18F-FDG

uPAR PET/CT and FDG PET/MR
Positron Emission Tomography and CTDEVICE

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

uPAR PET/CT and FDG PET/MR
Positron Emission Tomography and MRIDEVICE

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

uPAR PET/CT and FDG PET/MR

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy-verified urinary bladder cancer
  • The participants must be capable of understanding and giving full informed written consent age above 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisImage EnhancementPhotographyRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Dorthe Skovgaard, Md, PhD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Phd

Study Record Dates

First Submitted

June 13, 2016

First Posted

June 20, 2016

Study Start

September 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

April 11, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)