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

NCT02433171 | Terminated

• 1 other identifier: 1401013294
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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).

Conditions

Brain Metastasis

Keywords

regrowth; radiosurgery; radiation necrosis

Outcome Measures

Primary Outcomes (1)

• Change in Regrowing Tumor Rate from Radiation Effect

  6 months

Study Arms (2)

Melanoma Brain Metastases

Stage 4 cancer patient population with melanoma with brain metastases previously treated with SRS

Procedure: Standard of Care FDG-PET Imaging

Lung Cancer Brain Metastases

Stage 4 cancer patient population with non-small cell lung cancer with brain metastases previously treated with SRS

Procedure: Standard of Care FDG-PET Imaging

Interventions

Standard of Care FDG-PET Imaging PROCEDURE

\[11C\]Methionine \[11\]. This natural amino acid, and its various fluorinated derivatives, has been widely used in brain tumor studies due to a) high tumor-to-normal brain contrast, and b) its sensitivity to biological functions including amino acid transport and utilization. \[11C\]PBR28 \[12\]. This ligand is one of a series of second-generation tracers that bind to TSPO (translocator protein), a protein that is upregulated in activated microglia.

Also known as: DWI, MRPerfusion, MRSpectroscopy and FDG-PET

Lung Cancer Brain Metastases; Melanoma Brain Metastases

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

• 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.

  PMID: 33147119 DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Veronica Chiang, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: May 4, 2015
• Study Start: January 1, 2015
• Primary Completion: June 27, 2017
• Study Completion: June 27, 2017
• Last Updated: May 28, 2019

Record last verified: 2019-05

Locations

US (1)