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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04785521
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	IRCCS San Raffaele
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Pietro Mortini, MD, Prof.
Principal Investigator Affiliation	IRCCS San Raffaele
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Metastases, Adult

Additional Details

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.

Arms & Interventions

Arms

: BM patients

Adult patients carrying new diagnosed BM confirmed by MRI

: No BM patients

Adult patients carrying extracranial tumor without BM as confirmed by MRI

: Benign lesion patients

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

Interventions

Radiation: - Stereotactic radiosurgery

Gamma Knife stereotactic radiosurgery (SRS-GK)

Diagnostic Test: - 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.

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