Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04785521
Recruitment Status : Recruiting
First Posted : March 8, 2021
Last Update Posted : March 8, 2021
Sponsor:
Information provided by (Responsible Party):
Pietro Mortini, MD, Prof., IRCCS San Raffaele

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Brain Metastases, Adult Radiation: Stereotactic radiosurgery Diagnostic Test: Blood samples

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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Glutamate Excitotoxicity in Brain Metastases From Lung, Breast and Melanoma Treated With Stereotactic Radiosurgery
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
BM patients
Adult patients carrying new diagnosed BM confirmed by MRI
 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.
No BM patients
Adult patients carrying extracranial tumor without BM as confirmed by MRI
 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.
Benign lesion patients
Adult patients carrying intracranial extra-axial tumor as as confirmed by MRI
 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Blood samples

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Target group:

Adult patients affected by melanoma, breast or lung cancer BM of new diagnosis as confirmed by MRI ongoing SRS-GK treatment.

Control group 1:

Adult patients affected by melanoma, breast or lung cancer without BM.

Control group 2:

Adult patients affected by intracranial extra-axial benign tumor as confirmed by MRI ongoing SRS-GK treatment.

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04785521


Contacts
Layout table for location contacts
Contact: Laura Sincinelli 00390226435568 sincinelli.laura@hsr.it

Locations
Layout table for location information
Italy
IRCCS San Raffaele Scientific Institute Recruiting
Milan, Italy, 20132
Contact: Laura Sincinelli    003926435568    sincinelli.laura@hsr.it   
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
Layout table for investigator information
Principal Investigator: Pietro Mortini, MD, Prof. IRCCS San Raffaele
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Pietro Mortini, MD, Prof., Head of department, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT04785521    
Other Study ID Numbers: NCH04-2020
First Posted: March 8, 2021    Key Record Dates
Last Update Posted: March 8, 2021
Last Verified: March 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pietro Mortini, MD, Prof., IRCCS San Raffaele:
Brain metastases
Glutamate
Stereotactic radiosurgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplasms
Neoplastic Processes
Pathologic Processes
 Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases