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

Brain Metastasis Clinical Trial

Official title:

Studies of Methionine-PET and PBR28-PET in Brain Metastases to Differentiate Tumor Recurrence and Radiation Necrosis Following Stereotactic Radiosurgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02433171
• Other study ID #: 1401013294
• Status: Terminated
• Start date: January 2015
• Est. completion date: June 27, 2017

Study information

• Verified date: May 2019
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: June 27, 2017
• Est. primary completion date: June 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastasis
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

Procedure:
• Standard of Care FDG-PET Imaging
[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.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Regrowing Tumor Rate from Radiation Effect		6 months