An observational study in Carcinoma, Non-Small-Cell Lung and Brain Neoplasms, sponsored by University Hospital, Bordeaux. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by University Hospital, Bordeaux · Observational
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.
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.
6,705 studies on the registry are indexed under Carcinoma; 1,136 are open to participants now.
This study's planned enrollment of 38 is below the median of 149 across 1,169 observational studies indexed under Carcinoma.
Browse Carcinoma studies →University Hospital, Bordeaux is the lead sponsor of 805 studies on the registry; 196 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Other: Radiomic analysis; Bulk RNA sequencing
Radiomic analysis; Bulk RNA sequencing
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
Time frame: At diagnosis, before treatment initiation
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
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Jun 2028, 18 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Bordeaux →