AI & Radiomics for Stratification of Lung Nodules After Radically Treated Cancer
Recruiting · NCT05375591 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Non-Interventional Study
What this trial is about
This study will assess the utility of radiomics and artificial intelligence approaches to new lung nodules in patients who have undergone radical treatment for a previous cancer.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 it is running
2 locations listed.
- The Royal Marsden NHS Foundation Trust (Chelsea Site) - London, United Kingdom
- Royal Brompton Hospital - London, United Kingdom