Clinical Trials Directory

Trials / Terminated

TerminatedNCT02433171

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

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

Status
Terminated
Phase
Study type
Observational
Enrollment
8 (actual)
Sponsor
Yale University · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREStandard 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.

Timeline

Start date
2015-01-01
Primary completion
2017-06-27
Completion
2017-06-27
First posted
2015-05-04
Last updated
2019-05-28

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02433171. Inclusion in this directory is not an endorsement.