Clinical trial NCT02433171: Methionine and PBR28-PET (Peripheral Benzodiazepine Receptors) in Brain Metastases Following Radiosurgery
Official title: Studies of Methionine-PET and PBR28-PET in Brain Metastases to Differentiate Tumor Recurrence and Radiation Necrosis Following Stereotactic Radiosurgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Brain Metastasis
Keywords: regrowth
radiosurgery
radiation necrosis
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2015-05-04
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received SRS for melanoma or NSCLC brain metastases with regrowing lesions who are candidates for surgical intervention (biopsy or excision) at the Smilow Cancer Center or are candidates for monitoring by serial imaging will be screened for eligibility and offered enrollment

Brief summary: 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).

Detailed description: The investigators hypothesize that by using two different PET tracers, one sensitive to tumor metabolic activity, and one sensitive to inflammatory processes, investigators can separately identify metabolically active tumor from radiation necrosis related inflammation. This can be accomplished with quantitative assessments of tracer uptake using kinetic modeling techniques, as well as by high-resolution imaging to assess the distribution of tracer uptake in the tumor region. All participants in the study will have the receive the same diagnostic tests.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Regrowing Tumor Rate from Radiation Effect
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Veronica Chiang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tran TT, Gallezot JD, Jilaveanu LB, Zito C, Turcu G, Lim K, Nabulsi N, Huang H, Huttner A, Kluger HM, Chiang VL, Carson R. [11C]Methionine and [11C]PBR28 as PET Imaging Tracers to Differentiate Metastatic Tumor Recurrence or Radiation Necrosis. Mol Imaging. 2020 Jan-Dec;19:1536012120968669. doi: 10.1177/1536012120968669.