Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2025-12-24 @ 12:49 PM
NCT ID:
NCT03134261
Eligibility Criteria:
Inclusion Criteria:
A subject will be eligible for project participation if he meets all of the following 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:
A subject will be excluded from the protocol if he meets one or more of the following criteria:
* Has prior malignancy, except for adequately treated basal cell or squamous cell skin cancer
* Has pacemaker or implanted devices (eg. cardiac valves, neurostimulator or insulin pump) that cannot be removed, metal clips/metal prostheses from surgery that are not MRI compatible or metallic foreign bodies in the eye (MRI exclusion criteria)
* 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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03134261
Study Brief:
Protocol Section:
NCT03134261