Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of available funding.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastasis | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard of Care FDG-PET Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Melanoma Brain Metastases
- description
- Stage 4 cancer patient population with melanoma with brain metastases previously treated with SRS
- interventionNames
- Procedure: Standard of Care FDG-PET Imaging
- label
- Lung Cancer Brain Metastases
- description
- Stage 4 cancer patient population with non-small cell lung cancer with brain metastases previously treated with SRS
- interventionNames
- Procedure: Standard of Care FDG-PET Imaging
Primary outcomes (1)
- measure
- Change in Regrowing Tumor Rate from Radiation Effect
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDTran 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