Clinical trial · Observational
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)
NCT05375591CI-TRIAL-00058687AI-SONARrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Indeterminate Pulmonary Nodules | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Metastases | Lung Neoplasm | PROBABILISTIC | 0.70 |
| Second Primary Cancer | Second Primary Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Interventional Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Benign Nodules
- description
- 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.
- interventionNames
- Other: Non-Interventional Study
- label
- Metastatic Nodules
- description
- 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.
- interventionNames
- Other: Non-Interventional Study
- label
- Second Primary Lung Cancers
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (9)
- BACKGROUNDTabuchi T, Ito Y, Ioka A, Miyashiro I, Tsukuma H. Incidence of metachronous second primary cancers in Osaka, Japan: update of analyses using population-based cancer registry data. Cancer Sci. 2012 Jun;103(6):1111-20. doi: 10.1111/j.1349-7006.2012.02254.x. Epub 2012 Apr 11. PMID 22364479
- BACKGROUNDYoulden DR, Baade PD. The relative risk of second primary cancers in Queensland, Australia: a retrospective cohort study. BMC Cancer. 2011 Feb 23;11:83. doi: 10.1186/1471-2407-11-83. PMID 21342533
- BACKGROUNDStella GM, Kolling S, Benvenuti S, Bortolotto C. Lung-Seeking Metastases. Cancers (Basel). 2019 Jul 19;11(7):1010. doi: 10.3390/cancers11071010. PMID 31330946
- BACKGROUNDDeng L, Harethardottir H, Song H, Xiao Z, Jiang C, Wang Q, Valdimarsdottir U, Cheng H, Loo BW, Lu D. Mortality of lung cancer as a second primary malignancy: A population-based cohort study. Cancer Med. 2019 Jun;8(6):3269-3277. doi: 10.1002/cam4.2172. Epub 2019 Apr 16. PMID 30993899
- BACKGROUNDMery CM, Pappas AN, Bueno R, Mentzer SJ, Lukanich JM, Sugarbaker DJ, Jaklitsch MT. Relationship between a history of antecedent cancer and the probability of malignancy for a solitary pulmonary nodule. Chest. 2004 Jun;125(6):2175-81. doi: 10.1378/chest.125.6.2175. PMID 15189939
- BACKGROUNDJohnson BE. Second lung cancers in patients after treatment for an initial lung cancer. J Natl Cancer Inst. 1998 Sep 16;90(18):1335-45. doi: 10.1093/jnci/90.18.1335. PMID 9747865
- BACKGROUNDTravis LB. The epidemiology of second primary cancers. Cancer Epidemiol Biomarkers Prev. 2006 Nov;15(11):2020-6. doi: 10.1158/1055-9965.EPI-06-0414. Epub 2006 Oct 20. PMID 17057028
- Wilson R, Devaraj A. Radiomics of pulmonary nodules and lung cancer. Transl Lung Cancer Res. 2017 Feb;6(1):86-91. doi: 10.21037/tlcr.2017.01.04.