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 @ 10:08 PM
Ignite Modification Date:
2025-12-24 @ 10:08 PM
NCT ID:
NCT06159335
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or older
* Able and willing to provide informed consent
* Has a brain metastasis diagnosis with at least one single visible contrast enhancing metastatic lesion on brain MRI
* Received radiation therapy at some point in the last 2 years
* Is currently being treated with or has been treated with any other concurrent systemic therapy (multi-modal therapy) in the past 6 months, which would include immunotherapy, targeted therapy, or systemic chemotherapy, immunotherapy, or chemotherapy following radiation therapy.
* Patients are eligible for the study if their most recent standard-of-care MRI, used to assess disease location and extent, raises the question of tumor recurrence versus treatment-related changes. This concern can be noted by the radiologist or other members of the multidisciplinary care team, such as during a multidisciplinary conference. Additionally, if there are clinical concerns based on evolving exam findings or symptoms, and the treating physician suspects progression versus treatment-induced changes, the patient is also eligible for the study.
* Be able to lie still for 30-60 minutes during the imaging procedure
* Willing and able to undergo PET/MRI or PET/CT
* Patients requiring intravenous (IV) conscious sedation for imaging are not eligible; patients requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:
* The subject has their own prescription for the medication
* The informed consent process is conducted prior to the self-administration of this medication
* They come to the research visit with a driver
Exclusion Criteria:
* Subject unable or unwilling to provide informed consent
* Subject is pregnant
* Subject with contraindication(s) to or inability to undergo a PET/MR or PET/CT
* Known allergy to 18F-Fluciclovine or any of its excipients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06159335
Study Brief:
Protocol Section:
NCT06159335