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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2025-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Brain Metastases, Adult

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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BM patients

Adult patients carrying new diagnosed BM confirmed by MRI

Stereotactic radiosurgery

Intervention Type RADIATION

Gamma Knife stereotactic radiosurgery (SRS-GK)

Blood samples

Intervention Type 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.

No BM patients

Adult patients carrying extracranial tumor without BM as confirmed by MRI

Blood samples

Intervention Type 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.

Benign lesion patients

Adult patients carrying intracranial extra-axial tumor as as confirmed by MRI

Stereotactic radiosurgery

Intervention Type RADIATION

Gamma Knife stereotactic radiosurgery (SRS-GK)

Blood samples

Intervention Type 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.

Interventions

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Stereotactic radiosurgery

Gamma Knife stereotactic radiosurgery (SRS-GK)

Intervention Type RADIATION

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Adult patients carrying melanoma, breast or lung cancer BM of new diagnosis
* Patients eligible to SRS-GK treatment

\- Adult patients carrying melanoma, breast or lung cancer without BM

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No