RecruitingNCT05375591

AI & Radiomics for Stratification of Lung Nodules After Radically Treated Cancer

Artificial Intelligence & Radiomics for Stratification Of Lung Nodules After Radically Treated Cancer (AI-SONAR)

Sponsor

Royal Marsden NHS Foundation Trust

Enrollment

1,000 participants

Start Date

Oct 13, 2021

Study Type

OBSERVATIONAL

Conditions

Lung Cancer Lung Metastases Indeterminate Pulmonary Nodules Second Primary Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria15

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 Criteria3

CT Imaging \> 10 years old
Non-solid haematological malignancies including leukaemia
Cases of radically treated primary cancer disease with early oligometastatic recurrence treated radically

Interventions

OTHERNon-Interventional Study

First nodule detection CT scans as per eligibility criteria will be used as input into in-house software to extract multiple radiomic features and used to develop a machine learning based classifier to differentiate nodule aetiology. Scans will also be used as input in to a deep learning/convolutional neural network models to perform automated imaging classification.