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

Sponsor: Royal Marsden NHS Foundation Trust

NCT ID: NCT05375591

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Non-Interventional Study (other)
How long the study runs
Study runs about 61 months (dates as stated)
About the drug or intervention
Non-Interventional Study — other: 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.
Patient visit burden
Not specified by the sponsor

In plain English

This study, run by the Royal Marsden NHS Foundation Trust, is looking at whether artificial intelligence (AI) and computer analysis of CT (computed tomography) scans can help sort lung nodules into groups in people who have already been cured of another solid cancer. It covers people with indeterminate pulmonary nodules, lung metastases, second primary cancer, and lung cancer. The aim is to improve how these nodules are understood after cancer treatment.

Who can take part

  • You had a solid organ cancer treated with the aim of cure within the last 10 years, for example by surgery, radiotherapy, chemotherapy, or a combination, and the cancer went away or into remission
  • A new lung nodule of at least 5mm was found on a recent CT scan of your chest
  • What the nodule actually is (benign or cancer) is already known, from scans showing stability over 2 years, or from biopsy results, or from scans showing growth agreed by the medical team
  • Your CT scan used slices of 2.5mm thickness or thinner

Who may not be able to

  • Your CT scan is more than 10 years old
  • You have a non-solid blood cancer such as leukaemia
  • Your first cancer came back as a small number of spread spots (oligometastatic recurrence) that were then treated with the aim of cure

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
1,000
Started
2021-10-13
Last checked
2022-05

Plain English Summary

What is this study?

  • • Testing a new treatment for indeterminate pulmonary nodules
  • • Clinical study - 1,000 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with indeterminate pulmonary nodules

Where?

  • • London - The Royal Marsden NHS Foundation Trust (Chelsea Site)
  • • London - Royal Brompton Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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 outcomes. Recent retrospective studies in cancer survivors have demonstrated such patients possess an increased risk of further cancer in their lifetime compared to the general population, in part potentially due to shared lifestyle risk factors (e.g. smoking), genetic cancer pre-disposition or downstream oncogenic side effects of anti-cancer therapies (eg. radiotherapy). Lung cancer remains the leading cause of cancer related deaths worldwide and the lungs also represent a common site for metastatic disease in patients with non-pulmonary malignancy. Furthermore, lung cancer is one of the most common second primary malignancy in patients with a prior history of treated cancer. Therefore, discerning the significance of a pulmonary nodule in the context of a previous cancer remains a clinical challenge given it may possess the potential to represent benign disease, metastatic relapse or new primary malignancy. 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. This will entail use of machine learning (ML) approaches and later, exploration of deep-learning/convolutional neural network approaches to nodule interpretation for differentiation of benign, metastatic and new primary lung cancer nodules/lesions. Development of a ML classifier or deep learning based tool may help guide which patients would benefit from earlier investigations including additional imaging, biopsy sampling and lead to earlier cancer diagnosis, leading to better patient outcomes in this unique cohort. This is a retrospective study analysing data already collected routinely as part of patient care. All data will be anonymised prior to any analysis, no patient directed/related interventions will be employed and consent-waiver for study inclusion will be exercised.

Indeterminate Pulmonary NodulesLung MetastasesSecond Primary CancerLung Cancer

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Confirmed history of previous radically or curative-intent treated solid organ cancer within 10 years of new index...
  • ✓Biopsy confirming previous cancer with MDT consensus and successful cancer resolution/remission following...
  • ✓Radical treatment for previous cancer defined as either of the following:
  • ✓Surgical resection
  • ✓Radical radiotherapy or stereotactic beam radiotherapy

Who cannot take part

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

Where Is This Study? (2 UK sites)

The Royal Marsden NHS Foundation Trust (Chelsea Site)

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)
Richard LeePrincipal Investigator

Royal Brompton Hospital

London SW3 6NP, United Kingdom

Recruiting
Site contact (verified)
Anand DeverajPrincipal Investigator

How to Get in Touch

Sejal Jain

Sponsor contact

CONTACT

020 7808 2603 sejal.jain@rmh.nhs.uk

Laura Boddy

Sponsor contact

CONTACT

020 7808 2603 laura.boddy@rmh.nhs.uk
Data sourced from ClinicalTrials.gov · Last verified: 2022-05