New imaging methods for detecting brain tumors in patients with metastasis
Use of 18F-Fluciclovine PET for Discerning Tumor From Treatment Change in Patients With Brain Metastases Undergoing Immunotherapy
PHASE3 · University of Wisconsin, Madison · NCT06159335
This study is testing new imaging techniques to see if they can better detect brain tumors in patients who have cancer that has spread to the brain.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Wisconsin, Madison (other) |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT06159335 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of advanced imaging techniques, specifically positron emission tomography (PET) and magnetic resonance imaging (MRI), in detecting cancerous tissue in patients with brain metastasis. Participants will undergo a PET/MRI scan followed by a separate MRI scan with a tracer, with the entire process lasting about three hours. The study seeks to determine if these new imaging methods can identify tumors more accurately than existing imaging technologies, potentially leading to better cancer treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older with a diagnosed brain metastasis and at least one visible contrast-enhancing lesion on MRI.
Not a fit: Patients without a diagnosis of brain metastasis or those who have not received radiation therapy in the last two years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of tumor detection in patients with brain metastasis, leading to more effective treatment strategies.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for tumor detection, suggesting that this approach may yield beneficial results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Madison, Wisconsin
- University of Wisconsin — Madison, Wisconsin, United States (RECRUITING)
Study contacts
- Principal investigator: Michael Veronesi, MD, PhD — University of Wisconsin, Madison
- Study coordinator: Radiology Studies
- Email: radstudy@uwhealth.org
- Phone: 608-282-8349
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Brain Metastasis, Radiation Therapy, Immunotherapy, Active