Clinical trial · Observational
FDG PET/CT Radiomics Analyses of Lung Cancer Patients Treated With Immunotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators propose iRADIOMICS, a highly innovative and potentially clinical practice changing tool, which will allow for better management of patients undergoing immunotherapy. iRADIOMICS is based on in-depth interrogation of the molecular imaging (FDG PET/CT) data, extracting "invisible" information based on physical description of the imaging information. Based on the promising preliminary results of our pilot study, the investigators hypothesise that radiomics analyses of FDG PET/CT scans of patients treated with immunotherapy (iRADIOMICS) can better predict response to immunotherapy compared to the current standards (iRC). iRADIOMICS will be assessed in a prospective clinical study, involving 30 patients with metastatic non-small-cell lung cancer, treated with anti-programmed death-1 (anti-PD1) antibodies. Patients will undergo FDG PET/CT before the administration of anti-PD-1, at 1 month and 4 months after the administration. Afterwards, the patients will be imaged with FDG PET/CT every 6 months. Additionally, the patients will undergo diagnostic CT scan every 3 months to allow for comparison to the current standard (irRC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FDG PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Correlation of iRADIOMICS with survival
- timeFrame
- 1.1.2017 - 31.12.2020
- description
- To evaluate whether iRADIOMICS predicts response to immunotherapy better than irRC.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years; * Cytologically or histologically confirmed NSCLC with PD-L1 TPS ≥1% (confirmed by a validated test); * Stage IVa, IVb or recurrent NSCLC (classification IASLC, 7th edition, 2009); * Up to 10 metastases in multiple organ systems, or more than 10 metastases in more than two organ systems; * No signs of active and/or untreated brain metastases; * At least three measurable lesions; * Progression after the first or second-line systemic therapy; * WHO performance status 0-2 (ECOG criteria); * Following the decision of multidisciplinary board that the patient is a candidate for treatment with pembrolizumab; * FDG PET/CT performed up to 4 weeks prior to treatment; * Performed diagnostic CT scans (thorax and abdomen) up to 4 weeks prior to treatment; * Signed and dated written informed consent. Exclusion Criteria: Symptomatic and/or untreated brain metastases; * History of other malignancies, except for the following: adequately treated basal or squamous cell carcinoma of the skin, curatively treated in situ carcinoma of the uterine cervix, other curatively treated solid tumour with no evidence of disease for ≥ 3 years; * All contraindications for treatment with pembrolizumab.
References
Publications (0)
Data not yet available