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NCT Number: NCT04785521

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

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.

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Key information

Conditions

Brain Metastases, Adult Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS San Raffaele Scientific Institute

Milan, 20132, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stereotactic Radiosurgery

Radiation

Gamma Knife stereotactic radiosurgery (SRS-GK)

Blood samples

Diagnostic Test

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.

Primary outcomes

  1. Serum markers determination in newly diagnosed BM (lung, breast and melanoma) patients, before SRS treatment.

    Time frame: Baseline (pre-SRS);

    GOT1, GPT and LDH levels and serum glutamate, aspartate and lactate levels. All measures in mg/dl.

  2. Serum markers determination in newly diagnosed BM (lung, breast and melanoma) patients, after SRS treatment.

    Time frame: 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.

  3. Serum markers determination in melanoma, lung or breast cancer patients without BM.

    Time frame: 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.

  4. Serum markers determination in patients carrying benign intracranial lesions before and after SRS treatment.

    Time frame: 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 outcomes

  1. Studying correlation of serum markers levels with MRI changes following SRS-GK

    Time frame: 3, 6 and 9 months

    Correlation between trends of markers and incidence of MRI changes.

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Mar 8, 2021
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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