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18F-Fluciclovine PET/CT for Brain Cancer

Phase 2

Waitlist Available

Led By Bital Savir-Baruch, MD

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Known history of cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years from baseline

Awards & highlights

Study Summary

This trial aims to compare 18F-Fluciclovine uptake in brain lesions over 60 mins to help diagnose true progression vs. radionecrosis.

Who is the study for?

This trial is for adults over 18 with suspected or confirmed brain metastases from known cancer, who've had a positive MRI within the last two months and are scheduled for brain lesion treatment. They must be able to lie still for a PET/CT scan and sign consent. Excluded are those treated after their last MRI, with recent biopsies, prior brain surgery or radiation on the lesion, or unable to tolerate the exam.Check my eligibility

What is being tested?

The trial tests how well an imaging agent called 18F-Fluciclovine shows up in brain lesions using PET/CT scans. It compares uptake dynamics before and after treatment like surgery or radiation therapy against standard MRI results to distinguish true progression of disease from tissue damage due to treatment.See study design

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects of undergoing an 18F-Fluciclovine PET/CT may include discomfort lying still during scanning, allergic reactions to the tracer substance used (rare), and exposure to low levels of radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have a history of cancer.

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I have or might have cancer spread to my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years from baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years from baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years from baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assessment of the dynamics of 18F-fluciclovine uptake within recently treated metastatic brain lesions.

Characterization of the dynamics of 18F-fluciclovine uptake within a metastatic brain lesion over 60 mins.

Evaluate the potential use of 18F-fluciclovine in delineating true local progression from radionecrosis in patients with clinical uncertainty of indeterminate MRI.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 18F-Fluciclovine (Axumin) PET/CTExperimental Treatment1 Intervention

Patients with recently diagnosed brain metastatic lesion(s) will be recruited based on MRI with or without histological confirmation, per standard of care. All patients will undergo an 18F-fluciclovine head PET/CT scan prior to treatment for brain metastatic lesions, post treatment, and 3 years post treatment.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor

515 Previous Clinical Trials

148,694 Total Patients Enrolled

Blue Earth DiagnosticsIndustry Sponsor

38 Previous Clinical Trials

2,967 Total Patients Enrolled

Bital Savir-Baruch, MDPrincipal InvestigatorUniversity of Arizona

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this trial open to elderly persons over 75?

"This clinical research requires that all participants be aged between 18 and 99 in order to meet the eligibility criteria."

Answered by AI

Is it possible for me to register as a participant in this trial?

"To be eligible for this clinical trial, patients must possess a brain tumor and fall between the ages of 18 to 99. A maximum of 20 individuals are able to partake in this study."

Answered by AI

Is the use of 18F-Fluciclovine PET/CT officially sanctioned by the FDA?

"Since the 18F-Fluciclovine PET/CT clinical trial is in Phase 2, our team has assigned it a safety rating of 2. At this point there is some evidence to suggest its safety but no data detailing efficacy."

Answered by AI

Are recruitment efforts for this research effort still underway?

"Per clinicaltrials.gov, this trial is no longer recruiting patients. Originally posted on October 31st 2023 and last updated September 20th 2023, there are 924 other trials currently available for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility of 18F-Fluciclovine PET/CT to Identify Brain Metastasis

2024. "Feasibility of 18F-Fluciclovine PET/CT to Identify Brain Metastasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06055790.