Glutamate Excitotoxicity in Brain Metastases From Lung, Breast and Melanoma Treated With Stereotactic Radiosurgery
- Conditions
- Brain Metastases, Adult
- Interventions
- Diagnostic Test: Blood samplesRadiation: Stereotactic radiosurgery
- Registration Number
- NCT04785521
- Lead Sponsor
- IRCCS San Raffaele
- Brief Summary
Brain metastases (BM) represents a devastating clinical reality, carrying an estimated survival time of less than one year. Number of reasons, including complicated tumor biology and difficulties in modeling metastatic cancer in brain microenvironment, do hinder research on this topic. BM are indeed the most frequent neoplasm in the central nervous system (CNS) and is estimated that up to 14% of all newly diagnosed cancers will metastasize to the brain. A number of reasons, including complicated tumor biology and difficulties in modeling metastatic cancer in brain microenvironment, do hinder research on this topic. Present knowledge regarding alterations in Glutamate (Glu) homeostasis and BM is poor. This study aims at investigating Glu balance in BM patients and providing supporting evidence to the identification of new putative biomarkers to be used as potential therapeutic targets.
- Detailed Description
Experimental procedure:
Serum levels of glutamic oxaloacetic transaminase (GOT1), glutamate Pyruvate Transaminase (GPT) and lactate dehydrogenase (LDH) levels and serum glutamate, aspartate and lactate levels of a total of 100 patients will be collected and divided in three different groups:
* A: BM group (n=50), patients affected by BM from lung, breast and melanoma, candidates to SRS
* B: Control group 1 (n=25), patients with the same primary controlled tumors without nor brain nor extracranial metastases
* C: Control group 2 (n=25), patients with benign intracranial lesions candidates to SRS treatment.
In A) and C) serum GOT1, GPT and LDH levels and serum glutamate, aspartate, lactate levels will be evaluated before and after SRS treatment (at 3, 6 and 9 months follow-up).
In B) serum biomarkers levels will be only collected at baseline.
• Oncological and imaging data will be collected during follow-up in patients enrolled in the present studies. MRI imaging will be performed at definite timepoints (baseline and 3, 6 and 9 months follow-up).
Serum levels of markers will be analyzed in each group and results will be compared between them. Moreover, MRI changes and oncological relevant outcomes will be investigated.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Not provided
- Acute or chronic liver disease
- Severe anemia (Hb <8g/dl)
- Pregnant or breastfeeding patient
- Pediatric patients
- Patients not able to express informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description No BM patients Blood samples Adult patients carrying extracranial tumor without BM as confirmed by MRI Benign lesion patients Blood samples Adult patients carrying intracranial extra-axial tumor as as confirmed by MRI BM patients Blood samples Adult patients carrying new diagnosed BM confirmed by MRI Benign lesion patients Stereotactic radiosurgery Adult patients carrying intracranial extra-axial tumor as as confirmed by MRI BM patients Stereotactic radiosurgery Adult patients carrying new diagnosed BM confirmed by MRI
- Primary Outcome Measures
Name Time Method Serum markers determination in newly diagnosed BM (lung, breast and melanoma) patients, before SRS treatment. Baseline (pre-SRS); GOT1, GPT and LDH levels and serum glutamate, aspartate and lactate levels. All measures in mg/dl.
Serum markers determination in newly diagnosed BM (lung, breast and melanoma) patients, after SRS treatment. Baseline (pre-SRS) and at 3, 6 and 9 months GOT1, GPT and LDH levels and serum glutamate, aspartate and lactate levels. All measures in mg/dl.
Serum markers determination in melanoma, lung or breast cancer patients without BM. Baseline Comparison of serum GOT1, GPT and LDH levels and serum glutamate, aspartate and lactate levels between BM and non-BM patients. All measures in mg/dl.
Serum markers determination in patients carrying benign intracranial lesions before and after SRS treatment. Baseline (pre-SRS) and at 3, 6 and 9 months Comparison of serum GOT1, GPT and LDH levels and serum glutamate, aspartate and lactate levels between BM and benign lesion patients. All measures in mg/dl.
- Secondary Outcome Measures
Name Time Method Studying correlation of serum markers levels with MRI changes following SRS-GK 3, 6 and 9 months Correlation between trends of markers and incidence of MRI changes.
Trial Locations
- Locations (1)
IRCCS San Raffaele Scientific Institute
🇮🇹Milan, Italy