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Active, not recruiting Observational

Glutamate Excitotoxicity in Brain Metastases From Lung, Breast and Melanoma Treated With Stereotactic Radiosurgery

NCT04785521 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2020-07-01
Last updated
2025-06-11

Condition(s) studied

Brain Metastases, Adult

Investigational drug(s) / intervention(s)

Stereotactic radiosurgeryBlood samples

Stereotactic radiosurgery: Gamma Knife stereotactic radiosurgery (SRS-GK)

Blood samples: Serum Glu levels and Glu-regulation markers assessed prior to and following SRS-GK in BM or benign lesions or at baseline in non-BM patients.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria (Target group) * Adult patients carrying melanoma, breast or lung cancer BM of new diagnosis * Patients eligible to SRS-GK treatment Inclusion Criteria (Control group 1) \- Adult patients carrying melanoma, breast or lung cancer without BM Inclusion Criteria (Control group 2) * Adult patients carrying intracranial extra-axial benign tumor * Patients eligible to SRS-GK treatment Exclusion Criteria: * Acute or chronic liver disease * Severe anemia (Hb \<8g/dl) * Pregnant or breastfeeding patient * Pediatric patients * Patients not able to express informed consent

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
IRCCS San Raffaele Scientific Institute Milan Milan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04785521 on ClinicalTrials.gov ↗ ← All trials in Italy