Diagnostic Imaging of Bone Metastases in Prostate Cancer Patients
NCT ID: NCT03134261
Last Updated: 2017-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2014-04-30
2018-04-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
NONE
Study Groups
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SPECT-CT
The participants will undergo two project scans: WB-MRI and SPECT-CT
WB-MRI
scanning methods
SPECT-CT
scanning methods
Cholin-PET-CT
The participants will undergo two project scans: WB-MRI and Cholin-PET-CT
WB-MRI
scanning methods
Cholin-PET-CT
scanning methods
PSMA-PET-CT
The participants will undergo two project scans: WB-MRI and PSMA-PET-CT
WB-MRI
scanning methods
PSMA-PET-CT
Interventions
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WB-MRI
scanning methods
SPECT-CT
scanning methods
Cholin-PET-CT
scanning methods
PSMA-PET-CT
Eligibility Criteria
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Inclusion Criteria
* Is either 1) a newly diagnosed prostate cancer patient in clinical suspicion of bone metastases or 2) a previously diagnosed prostate cancer patient in clinical suspicion of progression in the form of bone metastases. The subject must have been referred to the standard diagnostic imaging (18F-NaF-PET-CT) at our institution for bone metastases.
* The prostate cancer diagnosis must be biopsy-proven
* The subject is willing and able to comply with the protocol as judged by the investigator
Exclusion Criteria
* Has prior malignancy, except for adequately treated basal cell or squamous cell skin cancer
* Has any condition that places the subject at an unacceptable risk if he undergoes a diagnostic CT-scan (e.g. history of severe allergic reaction to the contrast agent).
* Has severe obesity (\>195 kg is the weight limit for the scanner table)
* Has severe claustrophobia
18 Years
MALE
No
Sponsors
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Herlev Hospital
OTHER
Responsible Party
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Eva Dyrberg Mortensen
MD, Phd-student
Principal Investigators
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Henrik S. Thomsen, Professor
Role: STUDY_DIRECTOR
Department of Radiology
Locations
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Department of Radioogy/Department of Nuclear Medicine
Herlev, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DIMAB
Identifier Type: -
Identifier Source: org_study_id
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