Status:
RECRUITING
AI & Radiomics for Stratification of Lung Nodules After Radically Treated Cancer
Lead Sponsor:
Royal Marsden NHS Foundation Trust
Collaborating Sponsors:
Institute of Cancer Research, United Kingdom
National Institute for Health Research, United Kingdom
Conditions:
Indeterminate Pulmonary Nodules
Lung Metastases
Eligibility:
All Genders
18+ years
Brief 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.
Detailed Description
Improvements in cancer detection and diagnosis have led to increasing numbers of patients being diagnosed with early stage cancer and potentially receiving curative therapy with improved survival outc...
Eligibility Criteria
Inclusion
- 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
- CT Imaging \> 10 years old
- Non-solid haematological malignancies including leukaemia
- Cases of radically treated primary cancer disease with early oligometastatic recurrence treated radically
Key Trial Info
Start Date :
October 13 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT05375591
Start Date
October 13 2021
End Date
November 1 2026
Last Update
May 24 2022
Active Locations (2)
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1
The Royal Marsden NHS Foundation Trust (Chelsea Site)
London, United Kingdom, SW3 6JJ
2
Royal Brompton Hospital
London, United Kingdom, SW3 6NP