NCT03065725

Brief Summary

The aim of this study is to examine if late FDG-PET/CT images after intravenous FDG injection has a higher sensitivity and specificity in detecting local lymph node metastases in patients with muscle invasive BC than FDG-PET/CT images 60 minutes after FDG injection. The latter procedure has been used routinely until now.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
179

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

February 1, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 28, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2019

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

2.5 years

First QC Date

February 10, 2017

Last Update Submit

May 30, 2023

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

  • Patient with preoperatively detection of metastasis in lymph nodes

    Number of patients with metastasis proven in lymph nodes by preoperative PET/CT

    baseline

Interventions

late FDGPROCEDURE

In addition to regular FDG-PET/CT 60 minutes post injection, an extra scan 180 minutes post injection is made.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with bladder cancer scheduled for cystectomy

You may qualify if:

  • Patients diagnosed with BC who are candidates for cystectomy and undergo cystectomy with lymph node dissection or have a needle biopsy of at least one FDG-PET/CT local lymph node suspected for malignancy following the FDG-PET/CT due to their BC.

You may not qualify if:

  • Patients who have received chemotherapy, including neoadjuvant chemotherapy, in the timespan between the FDG-PET/CT and the needle biopsy or the lymph node dissection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital of West Jutland

Holstebro, Danmark, 7500, Denmark

Location

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 10, 2017

First Posted

February 28, 2017

Study Start

February 1, 2017

Primary Completion

August 13, 2019

Study Completion

January 1, 2022

Last Updated

May 31, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)