Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Multiple Pulmonary Nodules

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

In case of any nodule detection by qXR, it will be classified either as low-risk LNMS(lung nodule malignancy score ) or high-risk LNMS confirmed by radiologist. The patient will be requested to get a CT scan after enrolment in the study.

Patients coming to the facility for chest x-rays for any reason, will undergo x-rays as ordered by their treating clinician. In case of any nodule detection by qXR, it will be classified either as low-risk (Lung nodule malignancy score ) LNMS or high-risk LNMS confirmed by radiologist. Then if patient is eligible will be included in the study and a CT Scan will be requested upon enrolment of the patient.

Participant Cohort

AstraZeneca Clinical Study Information Center

Artificial intelligence (AI) based algorithms have demonstrated increased accuracy in predicting the risk of Lung Cancer among patients with an incidental pulmonary nodule (IPN) on chest radiographs. Qure.ai, an AI company specializing in the reading of chest X- Rays (CXRs) by a proprietary algorithm and has developed a new model, qXR, that can report the lung nodule malignancy score (LNMS) based on lung nodule features.

Our study aims to prospectively validate the lung nodule malignancy score against radiologist assessment of CT scans and Lung CT Screening Reporting and Data System score (Lung-RADS).(lung RADS score explained below) Thus, lung nodule malignancy score (interpreted by qXR as a high or low category) will be compared with radiologist-based assessment probability of CT scan and Lung-RADS assessment. The results of this prospective observational study will pave the way for improved nodule management, leading to better clinical outcomes in patients with incidental pulmonary nodule (IPNs), especially concerning malignancy assessment.

A multicentric, multinational, prospective, observational study to validate qXR-Lung nodule malignancy score as a binary categorization of the risk of Lung cancer as high or low among patients with an incidental pulmonary nodule (IPN) on chest radiographs. The study will be implemented across selected countries in the AstraZeneca International Region (e.g., Philippines, Malaysia, Saudi Arabia, United Arab Emirates, Kuwait, Thailand, Taiwan, Hong Kong, India, Brazil, Argentina, Colombia).

Patients coming to the facility for x-rays for any reason will undergo x-rays as ordered by their treating clinician. Adult patients diagnosed with incidental pulmonary nodule( IPN) on Chest X-ray (CXR) with nodule size ≥8 and ≤30 mm, will be invited to participate in the study and enrolled after obtaining their written informed consent. In case of any nodule detection by qXR, it will be classified either as low-risk Lung nodule malignancy score (LNMS) or high-risk LNMS. The X-ray reporting physician will decide the qXR report for the presence of a nodule.

CT scan will be performed after obtaining consent for the low-dose CT scan from patients.The clinical site's radiologist and an independent radiologist not associated with the clinical site will report the CT scan and the qXR-LNMS category. Radiologists' interpretation will be based on examining a nodule on a CT scan film (naked eye examination). Radiologists will first rate their CT scan interpretation of the nodule on the Likert scale as: non-malignant: 1; probable non-malignant: 2; uncertain: 3; probable malignant: 4; malignant: 5. In addition, the radiologists will assign a Lung-RADS and then give an overall assessment of the risk of malignancy as high or low.

. This study is minimal to no risk to the patient. The study duration for a participant will be approximately 30 months from the enrolment. The study will have 2 phases. Phase 1 will be from enrolment until CT data collection. The CT data collection day will end Phase 1 (End of Phase-1). Phase 2 will be from CT data collection until 24 months from CT which is the end of Phase 2. The study visits in this period will be per clinical follow-up and will not be mandatory.

We are not collecting any biospecimen sample.

Validating Artificial Intelligence Effectiveness Defined Lung Nodule Malignancy Score in Patients With Pulmonary Nodule.

Prospective Realworld Cohort Study to Validate Effectiveness of an Artificial Intelligence Defined Lung Nodule Malignancy Score in Patients With Pulmonary Nodule Multicentric, Multinational, Prospective, Observational Study.

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

PPV( positive predictive value) of qXR-LNMS using a panel of radiologists assigning high-risk based on CT (done within 180 days from Xray) as the reference standard The PPV here is the number of nodules rated as high risk as assessed by a reference standard (a panel of radiologists) on CT divided by the total number of high-risk nodules as reported by qXR-LNMS (lung nodule malignancy score ) (n = 500) NPV( negative predictive value) of qXR-LNMS using panel of radiologists assigning low-risk based on CT (done within 180days from X-ray) as reference standard.

The NPV here is number of nodules rated as low risk as assessed by a reference standard (a panel of radiologists) on CT divided by total number of low-risk nodules as reported by qXR-LNMS (lung nodule malignancy score ) (n = 200)

PPV (positive predictive value) of qXR-LNMS (lung nodule malignancy score) using panel of radiologists assigning Lung-RADS (lung RADS score explained in description )\>4A based on CT as reference standard.

The PPV here is number of nodules rated as Lung-RADS\>4A as assessed by a reference standard (a panel of radiologists) on CT divided by total number of high-risk nodules as reported by qXR-LNMS (n = 500) NPV ( negative predictive value) of qXR-LNMS using a panel of radiologists assigning Lung-RADS\<4A based on CT as the reference standard The NPV here is the number of nodules rated as Lung-RADS\<4A as assessed by a reference standard (a panel of radiologists) on CT divided by the total number of low-risk nodules as reported by qXR-LNMS (n = 200)

AstraZeneca

Symptoms and General Pathology

Neoplasm Metastasis

Carcinoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

The patients are offered high or lower dose according to usual practice

The Patient Decision Aid is used during the consultation to aid in the decision on high or lower dose.

The Patient Decision Aid informs about the pros and cons of each option

A Patient Decision Aid

Thomas L Fink, MD

A Patient Decision Aid (PtDA) is developed during a workshop in close collaboration with selected patients. The PtDA is subsequently used in the consultation between patient and physician to facilitate their shared decision on the dose of stereotactic body radiation therapy (SBRT) for lung tumors located less than 1 cm from the thoracic wall.

Hypothesis: The use of a PtDA will increase the extent of Shared Decision Making (SDM) during the consultation and result in patients being more directly involved in the planning of their treatment.

When a lung tumor is located close to the thoracic wall, there is an increased risk of developing chest wall pain or rib fracture following SBRT of the tumor. A meta-analysis has shown the pooled risk of chest wall pain to be 11% and that of rib fracture to be 6.3% with significant differences between individual studies. These side effects may occur several years after the treatment.

SDM is a collaborative process allowing patients and healthcare professionals to make decisions together taking into account the best scientific evidence as well as patients' values, preferences, life situation, and knowledge about disease process and prognosis.

PtDAs are tools designed to assist caregivers in the process of informing patients about relevant treatment options. PtDAs contain factual and balanced information about the options and the pertaining pros, cons, and probabilities. The tools are relevant when the decision is preference-sensitive, that is, the right treatment cannot be decided based on professional knowledge alone. The use of PtDAs has shown to provide a number of positive effects on the patients, including increased knowledge of options, better understanding of risks, and clarity as to what matters most in their life situation. Other effects are decreased decisional conflict and a higher degree of involvement in decision making.

This is a randomized trial enrolling eligible patients during a period of 16 months. SDM will be used in the planning of SBRT to patients with peripheral non-small cell lung tumors or lung metastases and offer them the choice between high (66 Gy in 3 fractions) and low (45 Gy in 3 fractions) radiation dose.

A total of 40 patients will be included in the study, i.e. 20 patients in each arm.

After inclusion in the study, the patients are randomized into Arm A and B as follows:

Arm A: Consultation as usual. Patients are informed about treatment and the two dose options according to current standards and routines.

Arm B: Consultation using the PtDA. Patients are informed about treatment and dose options using the PtDA to make the pros and cons clearer to the patients.

The doctors and nurses in the Radiotherapy Department will be educated in the use of the PtDA before initiation of the study.

Shared Decision Making on Radiation Dose for Lung Malignancies

Shared Decision Making on Radiation Dose for Stereotactic Body Radiotherapy of Malignancies Located Less Than 1 cm From the Thoracic Wall. A Randomized Trial

Anonymized data will be available on relevant request.

Minimum value: 0. Maximum value: 48. The higher the value, the higher the extent of SDM during the consultation

Minimum value 0. Maximum value 45. The higher the value, the higher the patient experienced extent of SDM during the consultation

Minimum value 0. Maximum value 4. The higher the value, the higher the patient experienced extent of SDM during the consultation

Minimum value 0. Maximum value 27. The higher the value, the higher the patient experienced extent of SDM during the consultation

Minimum value: 0. Maximum value: 64. The higher the value, the more decisional conflict.

Minimum value: 5. Maximum value: 25. The higher the value, the more decisional regret.

Minimum value: 0. Maximum value: 36. The higher the value, the more fear of recurrence.

Evaluated by the physician every three months the first two years and then every six months the following three years.

Thirty questions with two different scales (1-4 and 1-7). The higher the value, the more symptoms/problems.

Completed by the patients every three months the first two years and then every six months the following three years.

Twenty-nine questions on a scale from 1 to 4. The higher the value, the more symptoms/problems.

Completed by the patients every three months the first two years and then every six months the following three years.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Validating Artificial Intelligence Effectiveness Defined Lung Nodule Malignancy Score in Patients With Pulmonary Nodule.	NCT05817110	Lung Malignancy	Participant Coh...	35 Years -	AstraZeneca
Shared Decision Making on Radiation Dose for Lung Malignancies	NCT04940936	Decision Making... Stereotactic Bo... Lung Cancer, No... Radiation Toxic... Lung Metastases	A Patient Decis...	18 Years -	Vejle Hospital
Shared Decision Making on Radiation Dose for Lung Malignancies	NCT04940936	Decision Making... Stereotactic Bo... Lung Cancer, No... Radiation Toxic... Lung Metastases	A Patient Decis...	18 Years -	Vejle Hospital

Spots Global Cancer Trial Database for lung malignancy