Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2026-01-04 @ 8:44 PM
Study NCT ID:
NCT03134261
Status:
UNKNOWN
Last Update Posted:
2017-05-05
First Post:
2017-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Imaging of Bone Metastases in Prostate Cancer Patients
Sponsor:
Herlev Hospital
Organization:
Study Overview
Official Title:
A Prospective Study Comparing the Diagnostic Accuracy of Bone SPECT-CT, Choline-PET-CT, PSMA-PET-CT, NaF-PET-CT and WB-MRI in the Detection of Prostate Cancer Bone Metastases
Status:
UNKNOWN
Status Verified Date:
2017-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIMAB
Brief Summary:
An improved diagnosis of bone metastases in prostate cancer patients can have a significant impact on treatment strategy and probably survival as well.
The primary purpose of the project is to determine the diagnostic accuracy of bone SPECT-CT, choline-PET-CT, PSMA-PET-CT, NaF-PET-CT and Whole-body MRI in the diagnosis of bone metastases in prostate cancer patients.
The primary purpose of the project is to determine the diagnostic accuracy of bone SPECT-CT, choline-PET-CT, PSMA-PET-CT, NaF-PET-CT and Whole-body MRI in the diagnosis of bone metastases in prostate cancer patients.
Detailed Description:
The project is a prospective diagnostic test accuracy study. The project takes place at Herlev Hospital and is a collaboration between the Department of Radiology and the Department of Clinical Physiology and Nuclear Medicine.
The investigators want to include 300 prostate cancer patients referred to our standard diagnostic imaging (NaF-PET-CT scan) by the clinicians.
In addition to the standard diagnostic imaging (NaF-PET-CT-scan), two project will be performed on all participants. The project has three arms with the following scanning combinations:
A) Whole-body MRI + SPECT-CT B) Whole-body MRI + Cholin-PET-CT C) Whole-body MRI + PSMA-PET-CT The recruitment of project participants takes place on the day when the patients are undergoing a NaF-PET-CT scan in the course of regular clinical practice at our institution.
All readers are experienced radiologists or specialists in nuclear medicine. Patient identification on each scan will be anonymized and the reader will not have access to clinical and biochemical information or previous imaging studies.
The investigators want to include 300 prostate cancer patients referred to our standard diagnostic imaging (NaF-PET-CT scan) by the clinicians.
In addition to the standard diagnostic imaging (NaF-PET-CT-scan), two project will be performed on all participants. The project has three arms with the following scanning combinations:
A) Whole-body MRI + SPECT-CT B) Whole-body MRI + Cholin-PET-CT C) Whole-body MRI + PSMA-PET-CT The recruitment of project participants takes place on the day when the patients are undergoing a NaF-PET-CT scan in the course of regular clinical practice at our institution.
All readers are experienced radiologists or specialists in nuclear medicine. Patient identification on each scan will be anonymized and the reader will not have access to clinical and biochemical information or previous imaging studies.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: