Using AI to analyze lung nodules in cancer survivors
Artificial Intelligence & Radiomics for Stratification Of Lung Nodules After Radically Treated Cancer (AI-SONAR)
This study is testing if using artificial intelligence to analyze CT scans can help cancer survivors tell the difference between harmless lung nodules and those that might be cancerous.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal Marsden NHS Foundation Trust Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (London and 1 other locations) |
| Trial ID | NCT05375591 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of radiomics and artificial intelligence in assessing new lung nodules in patients who have previously undergone radical treatment for cancer. It aims to differentiate between benign nodules, metastatic disease, and new primary lung cancers using advanced machine learning techniques. The study will involve analyzing CT scans and potentially applying deep learning methods to improve diagnostic accuracy for these patients. By focusing on individuals with a history of cancer, the research addresses a critical clinical challenge in oncology.
Who should consider this trial
Good fit: Ideal candidates are patients with a confirmed history of radically treated solid organ cancer within the last 10 years who have developed new pulmonary nodules.
Not a fit: Patients without a history of previous cancer or those who do not have new pulmonary nodules will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses and better management of lung nodules in cancer survivors, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using AI and radiomics for cancer diagnosis, suggesting that this approach may yield beneficial results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed history of previous radically or curative-intent treated solid organ cancer within 10 years of new index CT thoracic scan demonstrating a new pulmonary nodule and either of the following: * Biopsy confirming previous malignancy with MDT consensus and successful cancer resolution/remission following anti-cancer treatment on interval imaging or blood assay analysis * Where biopsy was not possible/confirmed for previous malignancy, MDT consensus outcome confirming cancer (+/- calculated Herder score \>80% if applicable) and decision to treat as malignancy with subsequent resolution/remission following anti-cancer treatment on interval imaging or blood assay analysis * Radical treatment for previous cancer defined as either of the following: * Surgical resection * Radical radiotherapy or stereotactic beam radiotherapy * Radical chemotherapy * Radical chemo-radiotherapy * Multi-modality treatment with any of the above * New pulmonary nodule ground truth known * Scan data showing 2-year stability (based on diameter or volumetry) or resolution in cases of benign disease * Scan data showing progressive nodule enlargement or increase in nodule number on interval imaging with MDT consensus (+/- PET with Herder score \>80% if applicable) determining metastatic disease or new primary malignancy * Biopsy sampling confirming benign disease or malignancy and in cases of malignancy, metastasis or new primary lung cancer * CT scan slice thickness ≤ 2.5mm * Nodule size ≥ 5mm Exclusion Criteria: * CT Imaging \> 10 years old * Non-solid haematological malignancies including leukaemia * Cases of radically treated primary cancer disease with early oligometastatic recurrence treated radically
Where this trial is running
London and 1 other locations
- The Royal Marsden NHS Foundation Trust (Chelsea Site) — London, United Kingdom (Recruiting)
- Royal Brompton Hospital — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Richard Lee — The Royal Marsden Hospitals NHS Trust
- Study coordinator: Sejal Jain
- Email: sejal.jain@rmh.nhs.uk
- Phone: 020 7808 2603
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.