CarcinomaSIREC-PoumonNCT07904013
Impact of a Radiologic and Immunologic Signature on Cerebral Efficacy of Treatments in Lung Cancers With Brain Metastasis
An observational study of Carcinoma and Non-Small-Cell Lung, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Non-small cell lung cancer frequently spreads to the brain, and brain metastases are associated with poor prognosis and limited treatment response. This retrospective study will investigate whether quantitative features extracted from brain magnetic resonance imaging (MRI), known as radiomic features, are associated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Brain Neoplasms
- What is being tested?
- Radiomic analysis; Bulk RNA sequencing
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with advanced or metastatic non-small cell lung cancer diagnosed at Bordeaux University Hospital between 2017 and 2025, with at least one brain metastasis at diagnosis that was surgically resected and an indication for first-line immunotherapy and chemotherapy. Clinical, imaging, and biological data collected during routine care will be analyzed retrospectively
Who may be able to join
- Age 18 years or older
- Advanced or metastatic non-small cell lung cancer not amenable to local treatment
- At least one brain metastasis at diagnosis, surgically resected for symptomatic or high-risk disease and/or for diagnostic purposes
- Indication for first-line treatment with immunotherapy and chemotherapy
- Signed CHU de Bordeaux "one shot" form or receipt of the study information letter without opposition to participation within one month
Who cannot join
- Small cell lung cancer
- Resection performed for oligometastatic brain disease
- Oncogenic addiction amenable to targeted therapy
- Medical, psychiatric, or other condition preventing understanding of the study information or completion of the study
- Legal protection measure, including safeguard of justice, guardianship, or curatorship
- Deprivation of liberty by judicial or administrative decision
- Inability to provide consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de Bordeaux, Hôpital Saint-André
Bordeaux, 33000
Charlotte DOMBLIDES, +33 5 56 79 58 08, charlotte.domblides@chu-bordeaux.fr
About this study
Official title: Impact of an Immuno-radiomic Signature on Intracranial Treatment Efficacy in Non-small Cell Lung Cancer With Brain Metastases at Diagnosis
Non-small cell lung cancer frequently spreads to the brain, and brain metastases are associated with poor prognosis and limited treatment response. This retrospective study will investigate whether quantitative features extracted from brain magnetic resonance imaging (MRI), known as radiomic features, are associated with the immune characteristics of brain metastases assessed by bulk RNA sequencing. The main objective is to identify relationships between MRI-based radiomic signatures and tumor immune profiles. A secondary objective is to determine whether radiomic, transcriptomic, or combined radio-transcriptomic signatures can help predict cerebral progression during immunotherapy. The study hypothesis is that MRI-based radiomic signatures may reflect the immune environment of brain metastases and could provide a non-invasive approach for predicting treatment response.
Read the detailed description
Non-small cell lung cancer (NSCLC) is a major public health concern and is frequently diagnosed at an advanced or metastatic stage. Brain metastases occur frequently in patients with advanced NSCLC and are associated with poor prognosis and limited therapeutic response.
The tumor immune microenvironment plays an important role in tumor progression and treatment resistance. Several immune cell populations, including regulatory T lymphocytes, tumor-associated macrophages, and myeloid-derived suppressor cells, contribute to an immunosuppressive environment. The proportion and distribution of these immune populations may provide prognostic information and may influence response to systemic treatments, including immunotherapy. However, characterization of the immune microenvironment generally requires tissue sampling and may not provide a dynamic assessment of treatment response.
Radiomics is a quantitative imaging approach allowing automated extraction of multiple imaging features from medical images, including tumor shape, texture, signal characteristics, and characteristics of the surrounding tissue. Radiomic features can be integrated into machine-learning approaches to identify imaging patterns associated with clinically relevant biological characteristics. In NSCLC, previous studies have reported associations between radiomic signatures and molecular characteristics, treatment response, progression-free survival, and overall survival. However, no radiomic signature has been prospectively validated for routine clinical use in NSCLC.
The combination of radiomic and immune or transcriptomic data may provide complementary information regarding the biological characteristics of brain metastases. The present study will investigate whether MRI-derived radiomic signatures are associated with immune profiles obtained from bulk RNA sequencing of resected brain metastasis tissue.
The study will include 38 patients with metastatic NSCLC and at least one brain metastasis at diagnosis who were managed at Bordeaux University Hospital between 2017 and 2025. The study is retrospective and monocentric and will use clinical, imaging, and biological data collected as part of routine care.
Brain MRI examinations performed at diagnosis will be collected and pseudonymized. Tumor lesions and their surrounding tissues will undergo segmentation and quantitative radiomic analysis. Available tumor tissue samples from resected brain metastases will be identified, and RNA extraction followed by bulk RNA sequencing will be performed. Bioinformatic analyses will be used to characterize transcriptomic profiles and to investigate associations between radiomic and transcriptomic signatures.
Clinical and treatment data will be collected from medical records, including demographic characteristics, performance status, date of diagnosis, treatment initiation, histological characteristics, PD-L1 status, molecular status, characteristics of brain metastases, corticosteroid treatment, radiotherapy, cerebral progression, death, and last follow-up. Cerebral progression-free survival will be assessed using follow-up data.
The primary analysis will evaluate the correlation between the MRI-based radiomic signature and the transcriptomic signature obtained from bulk RNA sequencing. Secondary analyses will evaluate associations between radiomic, transcriptomic, and combined radio-transcriptomic signatures and cerebral progression-free survival.
The study will also explore whether distinct radiomic patterns are associated with different immune profiles, including relatively immune-low and immune-high profiles. An immune-low profile is expected to be associated with lower levels of cytotoxic T lymphocytes and antitumor M1 macrophages and higher levels of immunosuppressive populations such as myeloid-derived suppressor cells, M2 macrophages, and regulatory T lymphocytes.
The study may provide preliminary evidence supporting the use of MRI-derived radiomic signatures as a non-invasive surrogate of the immune characteristics of brain metastases. Such an approach could potentially allow longitudinal assessment of brain metastases using routine MRI and contribute to the development of predictive algorithms for treatment response. Further prospective validation would be required before clinical implementation.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Brain Neoplasms, Neoplasm Metastasis
- Being tested
- Radiomic analysis; Bulk RNA sequencing
- Keywords
- Chemo-immunotherapy, Non-small cell lung cancer, Brain metastases, Radiomics, Magnetic resonance imaging, RNA sequencing, Tumor immune microenvironment, Immunotherapy, Cerebral progression
- Medical subject headings
- Carcinoma, Brain Neoplasms, Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiomic analysis; Bulk RNA sequencingOther
Radiomic analysis; Bulk RNA sequencing
| Study group | Role | What they receive |
|---|---|---|
| Patients with brain metastases from NSCLC | Patients aged 18 years or older with advanced or metastatic non-small cell lung cancer, at least one resected brain metastasis at diagnosis, and an indication for first-line immunotherapy plus chemotherapy Receives: Other: Radiomic analysis; Bulk RNA sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between MRI-based radiomic signature and transcriptomic signature of brain metastases
Correlation between quantitative radiomic features extracted from brain MRI and transcriptomic profiles obtained from bulk RNA sequencing of resected brain metastasis tissue
Measured: At diagnosis, before treatment initiation
Secondary outcomes (1)
Correlation between radiomic signature and cerebral progression free survival (PFS) / correlation between transcriptomic signature and cerebral PFS / correlation between immunoradiomic signature and cerebral PFS
Association between the MRI-based radiomic signature and the time from diagnosis to cerebral progression or death
Measured: Once, at cerebral progression evaluated by MRI, or from date of death from any cause, or from date of last available follow-up, whichever came first from date of histologic diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07904013
- Sponsor's protocol ID
- CHUBX 2025/125
- Acronym
- SIREC-Poumon
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Immuno-radiomic Signature on Intracranial Treatment Efficacy in Non-small Cell Lung Cancer With Brain Metastases at Diagnosis
- ClinicalTrials.gov ID
- NCT07904013
- Acronym / sponsor ID
- SIREC-Poumon / CHUBX 2025/125
- Conditions
- Carcinoma, Non-Small-Cell Lung, Brain Neoplasms, Neoplasm Metastasis
- Keywords
- Chemo-immunotherapy, Non-small cell lung cancer, Brain metastases, Radiomics, Magnetic resonance imaging, RNA sequencing, Tumor immune microenvironment, Immunotherapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-small cell lung cancer frequently spreads to the brain, and brain metastases are associated with poor prognosis and limited treatment response. This retrospective study will investigate whether quantitative features extracted from brain magnetic resonance imaging (MRI), known as radiomic features, are associated with the immune characteristics of brain metastases assessed by bulk RNA sequencing. The main objective is to identify relationships between MRI-based radiomic signatures and tumor immune profiles. A secondary objective is to determine whether radiomic, transcriptomic, or combined radio-transcriptomic signatures can help predict cerebral progression during immunotherapy. The study hypothesis is that MRI-based radiomic signatures may reflect the immune environment of brain metastases and could provide a non-invasive approach for predicting treatment response.
Detailed description
Non-small cell lung cancer (NSCLC) is a major public health concern and is frequently diagnosed at an advanced or metastatic stage. Brain metastases occur frequently in patients with advanced NSCLC and are associated with poor prognosis and limited therapeutic response.
The tumor immune microenvironment plays an important role in tumor progression and treatment resistance. Several immune cell populations, including regulatory T lymphocytes, tumor-associated macrophages, and myeloid-derived suppressor cells, contribute to an immunosuppressive environment. The proportion and distribution of these immune populations may provide prognostic information and may influence response to systemic treatments, including immunotherapy. However, characterization of the immune microenvironment generally requires tissue sampling and may not provide a dynamic assessment of treatment response.
Radiomics is a quantitative imaging approach allowing automated extraction of multiple imaging features from medical images, including tumor shape, texture, signal characteristics, and characteristics of the surrounding tissue. Radiomic features can be integrated into machine-learning approaches to identify imaging patterns associated with clinically relevant biological characteristics. In NSCLC, previous studies have reported associations between radiomic signatures and molecular characteristics, treatment response, progression-free survival, and overall survival. However, no radiomic signature has been prospectively validated for routine clinical use in NSCLC.
The combination of radiomic and immune or transcriptomic data may provide complementary information regarding the biological characteristics of brain metastases. The present study will investigate whether MRI-derived radiomic signatures are associated with immune profiles obtained from bulk RNA sequencing of resected brain metastasis tissue.
The study will include 38 patients with metastatic NSCLC and at least one brain metastasis at diagnosis who were managed at Bordeaux University Hospital between 2017 and 2025. The study is retrospective and monocentric and will use clinical, imaging, and biological data collected as part of routine care.
Brain MRI examinations performed at diagnosis will be collected and pseudonymized. Tumor lesions and their surrounding tissues will undergo segmentation and quantitative radiomic analysis. Available tumor tissue samples from resected brain metastases will be identified, and RNA extraction followed by bulk RNA sequencing will be performed. Bioinformatic analyses will be used to characterize transcriptomic profiles and to investigate associations between radiomic and transcriptomic signatures.
Clinical and treatment data will be collected from medical records, including demographic characteristics, performance status, date of diagnosis, treatment initiation, histological characteristics, PD-L1 status, molecular status, characteristics of brain metastases, corticosteroid treatment, radiotherapy, cerebral progression, death, and last follow-up. Cerebral progression-free survival will be assessed using follow-up data.
The primary analysis will evaluate the correlation between the MRI-based radiomic signature and the transcriptomic signature obtained from bulk RNA sequencing. Secondary analyses will evaluate associations between radiomic, transcriptomic, and combined radio-transcriptomic signatures and cerebral progression-free survival.
The study will also explore whether distinct radiomic patterns are associated with different immune profiles, including relatively immune-low and immune-high profiles. An immune-low profile is expected to be associated with lower levels of cytotoxic T lymphocytes and antitumor M1 macrophages and higher levels of immunosuppressive populations such as myeloid-derived suppressor cells, M2 macrophages, and regulatory T lymphocytes.
The study may provide preliminary evidence supporting the use of MRI-derived radiomic signatures as a non-invasive surrogate of the immune characteristics of brain metastases. Such an approach could potentially allow longitudinal assessment of brain metastases using routine MRI and contribute to the development of predictive algorithms for treatment response. Further prospective validation would be required before clinical implementation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with brain metastases from NSCLC | – | Other: Radiomic analysis; Bulk RNA sequencingPatients aged 18 years or older with advanced or metastatic non-small cell lung cancer, at least one resected brain metastasis at diagnosis, and an indication for first-line immunotherapy plus chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with advanced or metastatic non-small cell lung cancer diagnosed at Bordeaux University Hospital between 2017 and 2025, with at least one brain metastasis at diagnosis that was surgically resected and an indication for first-line immunotherapy and chemotherapy. Clinical, imaging, and biological data collected during routine care will be analyzed retrospectively
Key inclusion criteria (5 listed)
- Age 18 years or older
- Advanced or metastatic non-small cell lung cancer not amenable to local treatment
- At least one brain metastasis at diagnosis, surgically resected for symptomatic or high-risk disease and/or for diagnostic purposes
- Indication for first-line treatment with immunotherapy and chemotherapy
- Signed CHU de Bordeaux "one shot" form or receipt of the study information letter without opposition to participation within one month
Key exclusion criteria (7 listed)
- Small cell lung cancer
- Resection performed for oligometastatic brain disease
- Oncogenic addiction amenable to targeted therapy
- Medical, psychiatric, or other condition preventing understanding of the study information or completion of the study
- Legal protection measure, including safeguard of justice, guardianship, or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiomic analysis; Bulk RNA sequencingRadiomic analysis; Bulk RNA sequencing | Other | Patients with brain metastases from NSCLC |
Primary outcome
Correlation between MRI-based radiomic signature and transcriptomic signature of brain metastases
Time frame: At diagnosis, before treatment initiation
Correlation between quantitative radiomic features extracted from brain MRI and transcriptomic profiles obtained from bulk RNA sequencing of resected brain metastasis tissue
1 secondary outcome
Correlation between radiomic signature and cerebral progression free survival (PFS) / correlation between transcriptomic signature and cerebral PFS / correlation between immunoradiomic signature and cerebral PFS
Time frame: Once, at cerebral progression evaluated by MRI, or from date of death from any cause, or from date of last available follow-up, whichever came first from date of histologic diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma and Non-Small-Cell Lung, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte DOMBLIDES (+33 5 56 79 58 08, charlotte.domblides@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between MRI-based radiomic signature and transcriptomic signature of brain metastases (time frame: At diagnosis, before treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.