Methionine and PBR28-PET (Peripheral Benzodiazepine Receptors) in Brain Metastases Following Radiosurgery

Stopped early

Conditions studied: Brain Metastasis

In brief

The goal of this protocol is to evaluate the potential of PET imaging of amino acid transport and microglial activation to improve the differentiation of tumor recurrence and radiation necrosis in patients with brain metastases after treatment with stereotactic radiosurgery (SRS) who have re-growing lesions. These state-of-the-art imaging tools will be used in combination with standard magnetic resonance imaging (MRI), MR spectroscopy (MRS) and FDG-PET (fluorodeoxyglucose).

Key facts

Study ID

NCT02433171

Run by

Yale University

People needed

8

Starts

2015-01-01

Expected to finish

2017-06-27

Last updated by the study team

2019-05-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients over 18 years with brain metastases from melanoma or non-small cell lung cancer
• Patients must have had SRS and regrowth in at least one lesion > 0.5 cm in greatest dimension and fall into one of two categories: a) patient is deemed clinically appropriate for surgical intervention (biopsy or craniotomy) OR b) patient is asymptomatic and has a life expectancy of > 6 months so that serial follow-up imaging is appropriate
• Willingness to participate in imaging studies
• Able to give informed consent

You may not qualify if…

• Subjects with history of prior radiation exposure for research purposes within the past year, such that participation in this study would place them over the FDA limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year.
• Subjects who are pregnant or currently breastfeeding
• Women of child-bearing age who are sexually active, unless they agree to two forms of contraception, and have a negative urine pregnancy test at screening and on the days of the PET imaging
• Patients unable to undergo MRI with gadolinium-based contrast for standard clinical reasons which include:
• Cardiac pacemaker, aneurysm clip, cochlear implants, Intra Uterine Device (IUD), shrapnel, neurostimulators, defibrillator, artificial heart valve, or history of metal fragments in eyes.
• Pregnancy
• Body size too large for closed MRI
• Known hepatic fibrosis.
• Claustrophobia
• Contraindication to MR contrast agents: eGFR (epidermal growth factor receptor) < 30 by the Cockcroft- Gault formula if > 60 years old or with chronic renal disease
• Anaphylactic allergy to gadolinium

Where it is running

• Yale University — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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