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18F-Fluciclovine PET/CT for Brain Cancer

Phase 2

Recruiting

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

Must not have

Patients who have had prior brain surgery or radiation treatment of the index lesion(s)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years from baseline

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had brain surgery or radiation for my current brain tumor.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 4Eligibility criteria met