[18F] Fluorocholine FCH Positron Emission Tomography (PET)/Computed Tomography (CT) for Detection of Prostate Cancer Lymph Nodes Metastases

Summary

The objective of this trial is to assess the value of 18F-choline PET/CT for the detection of regional lymph node metastases from prostate cancer. In addition, the investigators want to evaluate whether 18F-choline PET/CT can replace lymphadenectomy for the staging of prostate cancer.

Conditions

• Prostate Cancer

Interventions

PROCEDURE

[18F] Fluorocholine PET/CT

The patients fast 6 hours before the \[18F\]Fluorocholine PET/CT scan. \[18F\]Fluorocholine will be used as tracer with a dosage of 4 MBq per kg bodyweight. PET/CT imaging will be performed after 15 and 60 after the intravenous injection of the tracer. The patient will receive 2 full body FCH PET/CT. The CT scan is with contrast. The radiation exposure from the CT scan is 9 mSv and from the PET scan it is 3 mSv, giving a total of 12 mSv, which equals 4 times the yearly background radiation in Denmark.

Sponsors & Collaborators

• University of Southern Denmark

  collaborator OTHER

• Odense University Hospital

  lead OTHER

Principal Investigators

• Mads Hvid Poulsen, MD · Department of Urology, Odense University Hospital, Denmark

• Ulla Geertsen, MD, Head of Department · Department of Urology, Odense University Hospital, Denmark

• Niels Svolgaard, MD, Senior Physician · Department of Urology, Odense University Hospital, Denmark

• Steen Walter, MD, DMSci, Professor · Department of Urology, Odense University Hospital, Denmark

• Kirsten Bouchelouche, MD, DMSci · Odense University Hospital

• Mette Høilund-Carlsen, Head Technician · Odense University Hospital

• Henrik Petersen, MD, Senior Physician · Odense University Hospital

• Mattias Ögren, Radiochemist, PhD · Odense University Hospital

• Poul F Høilund-Carlsen, MD, DMSci, Professor · Department of Nuclear Medicine, Odense University Hospital, Demnark

• Oke Gerke, Post-Doc, PhD · University of Southern Denmark

• Werner Vach, PhD, Professor · University of Southern Denmark

• Birgitte Svolgaard, MD, Senior Physician · Odense University Hospital

• Niels Marcussen, MD, DMSci, Professor · Odense University Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Model

SINGLE_GROUP

Eligibility

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-01-31

Primary Completion

2013-02-28

Completion

2013-04-30

Countries

• Denmark

Study Locations