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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
View:

• 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

Locations
Other Locations
United Kingdom
Royal Brompton Hospital
RECRUITING
London
The Royal Marsden NHS Foundation Trust (Chelsea Site)
RECRUITING
London
Contact Information
Primary
Sejal Jain
sejal.jain@rmh.nhs.uk
020 7808 2603
Backup
Laura Boddy
laura.boddy@rmh.nhs.uk
020 7808 2603
Time Frame
Start Date: 2021-10-13
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 1000
Treatments
Benign Nodules
CT scans of patients with a new lung nodule(s) subsequently confirmed to be benign and in the context of a previous history of radically treated cancer, will be identified at participating NHS sites and recruited.
Metastatic Nodules
CT scans of patients with a new lung nodule(s) subsequently confirmed to be metastatic in nature and in the context of a previous history of radically treated cancer, will be identified at participating NHS sites and recruited.
Second Primary Lung Cancers
CT scans of patients with a new lung nodule(s) subsequently confirmed to be a new second primary lung cancer and in the context of a previous history of radically treated cancer, will be identified at participating NHS sites and recruited.
Sponsors
Collaborators: National Institute for Health Research, United Kingdom, Royal Brompton & Harefield NHS Foundation Trust, Imperial College London, Royal Marsden Partners Cancer Alliance, National Heart and Lung Institute, Institute of Cancer Research, United Kingdom, Oxford University Hospitals NHS Trust
Leads: Royal Marsden NHS Foundation Trust

This content was sourced from clinicaltrials.gov

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