Ignite Creation Date:
2024-05-06 @ 12:25 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03753724
Status:
COMPLETED
Last Update Posted:
2022-07-29
First Post:
2018-08-15
Brief Title:
IDEAL Artificial Intelligence and Big Data for Early Lung Cancer Diagnosis Study
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
IDEAL Artificial Intelligence and Big Data for Early Lung Cancer Diagnosis Prospective Study Phase 2
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IDEAL
Brief Summary:
This study aims to test the use of novel CT image analysis techniques to enable a better characterisation of small pulmonary nodules The study will incorporate solid and predominantly solid nodules of 5-15 mm scanned using a variety of scanner types imaging protocols and patient populations The investigators hope that the new image processing techniques will improve the accuracy of lung nodule analysis which will in turn reduce the number of unnecessary investigations for benign nodules and may increase the accuracy of the early diagnosis of lung cancer in malignant nodules This study aims to test this novel analysis software to subsequently allow validation
Detailed Description:
As the commonest cancer with 18 million cases diagnosed each year worldwide early diagnosis of lung cancer is important to reduce mortality The early diagnosis of lung cancer is contingent on both the detection of a small lung nodule and determining whether it is malignant Whilst computed tomography CT has proven to be a robust way of detecting lung nodules they are often discovered on routine scanning as an incidental finding or as part of a lung cancer screening program Hence determining whether they are benign or malignant is challenging
Up to 75 of smokers scanned either as part of their clinical care or in lung cancer screening trials have subcentimetre pulmonary nodules detected This places a substantial burden on scanning facilities staff and patients Current methods of determining if lung nodules are benign or malignant are not standardised and unproven The US National Lung Screening Trial NLST showed that up to 95 of lung nodules detected on CT scans of the chest were false positives ie they were not malignant Detection of non-malignant nodules have the unwanted consequences of unnecessary cost as they require follow-up scanning or alternative methods of investigation cause patient anxiety may result in increased morbidity potentially by biopsy or resection and result in increased patient radiation exposure due to follow-up CT scans or from PET-CT scans
As part of standard care at present patients with lung nodules greater than 4mm and sub-centimetre are followed up with CT scans up to 5 scans for up to 24 months according to the internationally accepted Fleischner guidelines Additional investigations such as a positron-emission tomography PET-CT scan and biopsy or resection may also be performed based on the size and clinical risk profile of the patient
Recent studies have shown that incorporating lung nodule characteristics such as size texture growth rate contrast enhancement can improve the accuracy of predicting the risk of malignancy This allows the stratification of lung nodules into different investigations andor follow-up pathways based on the predicted risk of malignancy
This study aims to test the use of novel CT image analysis techniques incorporated into a clinical risk model to characterise small pulmonary nodules The study will incorporate solid and predominantly solid nodules of 5-15mm scanned using a variety of scanner types imaging protocols and patient populations
CT scans from patients referred to the Lung Nodule Clinic or for review by a specialist in nodule assessment as per current clinical practice will be reviewed Patients who meet the inclusionexclusion criteria will be contacted by a member of the clinical care team and study participation will be discussed
Of the nodules detected their management will be categorised as per standard care into the following groups
GROUP 1 On review of the scans by an expert no further follow up or investigation is required as the nodules has been categorised as benign As the patient was unaware the scan was being reviewed and no further investigations are required Patient is invited to take part in the study by telephone
GROUP 2 On review the nodule is indeterminate and further scanning at a later date is required The patient is informed of this usually via a telephone call from either the doctor or nurse specialist working in the Lung Nodule Clinic LNC or site equivalent This LNC is usually a virtual clinic - no physical interaction with the patient - and the follow up scan is reviewed and the patient contacted again via the virtual clinic Patient is invited to take part in the study by telephone by post or in clinic if appropriate
GROUP 3 On review the nodule is regarded as potentially malignant and further scans and a clinic appointment is made for the patient Patient is invited to take part in the study in clinic if appropriate
Apart from CT images routine care clinical information about the patient eg age sex smoking status family history of lung cancer and data on nodule characteristics derived from the identified CT scan andor prior and subsequent will be collected and used to test the new software program that will stratify pulmonary nodules in terms of their probability of being malignant or benign All this data is routine and is collected as part of standard care therefore no study visits will need to be arranged
As part of the health economics assessment patients will be invited to complete the EQ-5D-5L quality of life GAD-7 anxiety and productivity loss questionnaires Patients will also be asked questions about their health utilisation This data may also be collected from medical noteselectronic patient records
The initial questionnaires will be completed within 2 weeks if possible of having the first scan and a follow-up will be carried out after 1 year for group 1 participants Group 2 and 3 participants will also be invited to complete these questionnaires 3 months after their initial scan as they will have undergone further investigations during that time The questionnaires will be completed over the phone for patients in groups 1 and over the phone or face to face when attending routine clinic appointments for groups 2 and 3
Up to 75 of smokers scanned either as part of their clinical care or in lung cancer screening trials have subcentimetre pulmonary nodules detected This places a substantial burden on scanning facilities staff and patients Current methods of determining if lung nodules are benign or malignant are not standardised and unproven The US National Lung Screening Trial NLST showed that up to 95 of lung nodules detected on CT scans of the chest were false positives ie they were not malignant Detection of non-malignant nodules have the unwanted consequences of unnecessary cost as they require follow-up scanning or alternative methods of investigation cause patient anxiety may result in increased morbidity potentially by biopsy or resection and result in increased patient radiation exposure due to follow-up CT scans or from PET-CT scans
As part of standard care at present patients with lung nodules greater than 4mm and sub-centimetre are followed up with CT scans up to 5 scans for up to 24 months according to the internationally accepted Fleischner guidelines Additional investigations such as a positron-emission tomography PET-CT scan and biopsy or resection may also be performed based on the size and clinical risk profile of the patient
Recent studies have shown that incorporating lung nodule characteristics such as size texture growth rate contrast enhancement can improve the accuracy of predicting the risk of malignancy This allows the stratification of lung nodules into different investigations andor follow-up pathways based on the predicted risk of malignancy
This study aims to test the use of novel CT image analysis techniques incorporated into a clinical risk model to characterise small pulmonary nodules The study will incorporate solid and predominantly solid nodules of 5-15mm scanned using a variety of scanner types imaging protocols and patient populations
CT scans from patients referred to the Lung Nodule Clinic or for review by a specialist in nodule assessment as per current clinical practice will be reviewed Patients who meet the inclusionexclusion criteria will be contacted by a member of the clinical care team and study participation will be discussed
Of the nodules detected their management will be categorised as per standard care into the following groups
GROUP 1 On review of the scans by an expert no further follow up or investigation is required as the nodules has been categorised as benign As the patient was unaware the scan was being reviewed and no further investigations are required Patient is invited to take part in the study by telephone
GROUP 2 On review the nodule is indeterminate and further scanning at a later date is required The patient is informed of this usually via a telephone call from either the doctor or nurse specialist working in the Lung Nodule Clinic LNC or site equivalent This LNC is usually a virtual clinic - no physical interaction with the patient - and the follow up scan is reviewed and the patient contacted again via the virtual clinic Patient is invited to take part in the study by telephone by post or in clinic if appropriate
GROUP 3 On review the nodule is regarded as potentially malignant and further scans and a clinic appointment is made for the patient Patient is invited to take part in the study in clinic if appropriate
Apart from CT images routine care clinical information about the patient eg age sex smoking status family history of lung cancer and data on nodule characteristics derived from the identified CT scan andor prior and subsequent will be collected and used to test the new software program that will stratify pulmonary nodules in terms of their probability of being malignant or benign All this data is routine and is collected as part of standard care therefore no study visits will need to be arranged
As part of the health economics assessment patients will be invited to complete the EQ-5D-5L quality of life GAD-7 anxiety and productivity loss questionnaires Patients will also be asked questions about their health utilisation This data may also be collected from medical noteselectronic patient records
The initial questionnaires will be completed within 2 weeks if possible of having the first scan and a follow-up will be carried out after 1 year for group 1 participants Group 2 and 3 participants will also be invited to complete these questionnaires 3 months after their initial scan as they will have undergone further investigations during that time The questionnaires will be completed over the phone for patients in groups 1 and over the phone or face to face when attending routine clinic appointments for groups 2 and 3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None