Lung Cancer ScreeningNCT06531343
Advancing Lung Cancer Screening: Artificial Intelligence, Multimodal Imaging and Cutting-Edge Technologies for Early Detection and Characterization
A study testing LDCT scan and simultaneous [18F]FDG PET/CT on new-generation long axial field of view scanner and LDTC only in people with Lung Cancer Screening, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Currently available screening programmes for lung cancer are limited by many challenges including low diagnostic accuracy, radiation exposure and high costs. New technologies in PET/CT scanners can allow cheaper and more sensitive exams with low radiation exposure. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Lung Cancer Screening
- What is being tested?
- LDCT scan and simultaneous [18F]FDG PET/CT on new-generation long axial field of view scanner and LDTC only
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 1 siteItaly
- Study dates
- 30 Oct 2024to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 50 years
- PLCOm2012 risk prediction > 4%
- Be willing to adhere to the study intervention through [18F]FDG PET/CT or LDCT imaging
- Signed written informed consent form
Who cannot join
- Blood glucose levels >200 mg/dl,
- Ongoing pregnancy and breastfeeding
- Unwillingness to participate,
- Previous diagnosis of lung cancer,
- Previous CT scan within the last 24 months
- Concomitant severe clinical conditions and any condition that preclude the feasibility of the study
Trial locations and contacts
1 site in 1 country.
Italy1 site
Irccs San Raffaele
Milan
Arturo Chiti, 0226432716, chiti.arturo@hsr.it
Rachele Di Donato, 0226433639, didonato.rachele@hsr.it
About this study
Currently available screening programmes for lung cancer are limited by many challenges including low diagnostic accuracy, radiation exposure and high costs. New technologies in PET/CT scanners can allow cheaper and more sensitive exams with low radiation exposure. AI can be used to denoise LDCT to enhance the accuracy of imaging tests and build riskassessment models. This project aims to develop a new approach exploiting both these revolutionary advancements to bridge the existing gap in lung cancer screening. Patients in a high-risk population will be enrolled into two different cohorts undergoing LDCT scan and simultaneous [18F]FDG PET/CT on new-generation long axial field of view scanner (UO1) or screening with low LDCT only (UO2). AI will assist in image enhancement and interpretation and will develop a personalised risk-model guiding the following steps of clinical management, significantly improving early diagnosis of lung cancer, reducing mortality and healthcare costs.
Read the detailed description
Assessment of the potential added value of low dose [18F]FDG PET/CT in the early detection of lung cancer in the screening work-up of the high-risk population. The target population (cohort 1) for the multimodal screening programme will be identified at UO1 on the basis of the PLCOM2012 prediction risk model. All patients enrolled in cohort 1 will undergo a LDCT and a simultaneous low dose [18F]FDG PET scan. Whole body [18F]FDG PET/CT will be performed according to EANM Guidelines for tumour imaging. Briefly, patients will be instructed to fast for 6 hours and to avoid strenuous physical activity for 48 hours prior to the PET/CT scan. Diabetic patients will be instructed to fast for 4 hours prior to the scan and will be instructed on the use of medications according to the institution's protocol. Blood glucose levels will be checked, [18F]FDG will be injected intravenously, and PET/CT images will be acquired after 60 minutes (± 10 minutes). A new generation long axial field of view PET/CT scanner (Omni Legend, General Electric Healthcare, Waukesha, WI, USA) will be used for whole body imaging.
The control population (cohort 2) will be identified in UO2 on the basis of the PLCOM2012 prediction risk model as previously described for cohort 1. The LDCT scan will be performed in single deep inspiratory breath hold. No intravenous contrast will be administered. LDCT images will be assessed and interpreted by at least two experienced radiologists. LDCT will be defined as positive if at least one non-calcified lung nodule >5 mm in any diameter is detected. LDCT will be defined as negative if no clinically significant morphological alterations are detected. Non-calcified nodules of 3-5mm detected by LDCT will be reported. Lung-RADS criteria will be used to classify detected lung nodules. Any other suspicious morphological alteration will be reported. The number, size, characteristics, and location of any lesion detected will be recorded for each LDCT scan. Any abnormality suggestive of clinically significant conditions other than cancer will be also reported. Sensitivity, specificity, and accuracy will be calculated by per-patient and per-lesion analysis.
- Conditions
- Lung Cancer Screening
- Being tested
- LDCT scan and simultaneous [18F]FDG PET/CT on new-generation long axial field of view scanner, LDTC only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LDCT scan and simultaneous [18F]FDG PET/CT on new-generation long axial field of view scannerProcedure or surgery
18F]FDG will be injected intravenously, and PET/CT images will be acquired after 60 minutes (± 10 minutes). PET/CT images will be first analysed with the lung window to detect any findings suggestive of a lung tumour.
Whole-body PET/CT images will be then analysed to detect any incidental finding in the chest as well as other anatomical areas included in the field of view. PET/CT images will be considered positive if there is at least one non-calcified lung nodule or any suspicious finding on CT scan characterised by focal [18F]FDG uptake deviating from physiological distribution or above physiological background activity.
LDTC onlyProcedure or surgery
The LDCT scan will be performed in single deep inspiratory breath hold. No intravenous contrast will be administered.
| Study group | Role | What they receive |
|---|---|---|
| LDCT scan and simultaneous [18F]FDG PET/CT on new-generation long axial field of view scanner | Experimental | Not described Receives: Procedure: LDCT scan and simultaneous [18F]FDG PET/CT on new-generation long axial field of view scanner |
| low LDCT only | Active comparator | Not described Receives: Procedure: LDTC only |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to assess the diagnostic accuracy of low-dose [18F]FDG PET/CT for screening in high-risk individuals or lung cancer Time Frame:
The primary endpoint is the detection rate of [18F]FDG PET/CT for suspicious lung nodules. The sensitivity, specificity and accuracy will be calculated by a per-patient and per-lesion analysis based on the clinico-radiological follow-up.
PET/CT images will be considered positive if there is at least one non-calcified lung nodule or one suspicious finding on CT scan characterised by focal [18F]FDG uptake that deviates from the physiological distribution or is above the physiological background activity. If there are no areas of increased uptake compared to physiological background activity, PET/CT images are considered negative.
Measured: 24 months
Secondary outcomes (1)
Assessment of the diagnostic accuracy of LDCT alone for screening in high-risk individuals or lung cancer and accuracy of [18F]FDG PET/CT for the additional detection of non-lung cancers in a high-risk population.
The sensitivity, specificity and accuracy will be calculated by a per-patient and per-lesion analysis based on the clinico-radiological follow-up. LDCT will be defined as positive if at least one non-calcified lung nodule >5 mm in any diameter is detected. LDCT will be defined as negative if no clinically significant morphological alterations are detected. Lung-RADS criteria will be used to classify detected lung nodules.
PET/CT images will be considered positive if there is at least one suspicious morphological finding on CT scan characterised by focal [18F]FDG uptake that deviates from the physiological distribution or is above the physiological background activity. If there are no areas of increased uptake compared to physiological background activity, PET/CT images are considered negative.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start30 Oct 2024 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Policlinico Universitario Campus Bio-Medico, University of Calabria, University of Salerno
- Responsible party
- Principal investigator, Chiti Arturo, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531343
- Sponsor's protocol ID
- PNRR-MCNT2-2023-12377755
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Lung Cancer Screening: Artificial Intelligence, Multimodal Imaging and Cutting-Edge Technologies for Early Detection and Characterization
- ClinicalTrials.gov ID
- NCT06531343
- Acronym / sponsor ID
- PNRR-MCNT2-2023-12377755
- Conditions
- Lung Cancer Screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 334 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Fondazione Policlinico Universitario Campus Bio-Medico, University of Calabria, University of Salerno
- Study start
- 30 Oct 2024 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently available screening programmes for lung cancer are limited by many challenges including low diagnostic accuracy, radiation exposure and high costs. New technologies in PET/CT scanners can allow cheaper and more sensitive exams with low radiation exposure. AI can be used to denoise LDCT to enhance the accuracy of imaging tests and build riskassessment models. This project aims to develop a new approach exploiting both these revolutionary advancements to bridge the existing gap in lung cancer screening. Patients in a high-risk population will be enrolled into two different cohorts undergoing LDCT scan and simultaneous [18F]FDG PET/CT on new-generation long axial field of view scanner (UO1) or screening with low LDCT only (UO2). AI will assist in image enhancement and interpretation and will develop a personalised risk-model guiding the following steps of clinical management, significantly improving early diagnosis of lung cancer, reducing mortality and healthcare costs.
Detailed description
Assessment of the potential added value of low dose [18F]FDG PET/CT in the early detection of lung cancer in the screening work-up of the high-risk population. The target population (cohort 1) for the multimodal screening programme will be identified at UO1 on the basis of the PLCOM2012 prediction risk model. All patients enrolled in cohort 1 will undergo a LDCT and a simultaneous low dose [18F]FDG PET scan. Whole body [18F]FDG PET/CT will be performed according to EANM Guidelines for tumour imaging. Briefly, patients will be instructed to fast for 6 hours and to avoid strenuous physical activity for 48 hours prior to the PET/CT scan. Diabetic patients will be instructed to fast for 4 hours prior to the scan and will be instructed on the use of medications according to the institution's protocol. Blood glucose levels will be checked, [18F]FDG will be injected intravenously, and PET/CT images will be acquired after 60 minutes (± 10 minutes). A new generation long axial field of view PET/CT scanner (Omni Legend, General Electric Healthcare, Waukesha, WI, USA) will be used for whole body imaging.
The control population (cohort 2) will be identified in UO2 on the basis of the PLCOM2012 prediction risk model as previously described for cohort 1. The LDCT scan will be performed in single deep inspiratory breath hold. No intravenous contrast will be administered. LDCT images will be assessed and interpreted by at least two experienced radiologists. LDCT will be defined as positive if at least one non-calcified lung nodule >5 mm in any diameter is detected. LDCT will be defined as negative if no clinically significant morphological alterations are detected. Non-calcified nodules of 3-5mm detected by LDCT will be reported. Lung-RADS criteria will be used to classify detected lung nodules. Any other suspicious morphological alteration will be reported. The number, size, characteristics, and location of any lesion detected will be recorded for each LDCT scan. Any abnormality suggestive of clinically significant conditions other than cancer will be also reported. Sensitivity, specificity, and accuracy will be calculated by per-patient and per-lesion analysis.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LDCT scan and simultaneous [18F]FDG PET/CT on new-generation long axial field of view scanner | Experimental | Procedure: LDCT scan and simultaneous [18F]FDG PET/CT on new-generation long axial field of view scanner |
| low LDCT only | Active comparator | Procedure: LDTC only |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 50 years
- PLCOm2012 risk prediction > 4%
- Be willing to adhere to the study intervention through [18F]FDG PET/CT or LDCT imaging
- Signed written informed consent form
Key exclusion criteria (6 listed)
- Blood glucose levels >200 mg/dl,
- Ongoing pregnancy and breastfeeding
- Unwillingness to participate,
- Previous diagnosis of lung cancer,
- Previous CT scan within the last 24 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LDCT scan and simultaneous [18F]FDG PET/CT on new-generation long axial field of view scanner18F]FDG will be injected intravenously, and PET/CT images will be acquired after 60 minutes (± 10 minutes). PET/CT images will be first analysed with the lung window to detect any findings suggestive of a lung tumour. Whole-body PET/CT images will be then analysed to detect any incidental finding in the chest as well as other anatomical areas included in the field of view. PET/CT images will be considered positive if there is at least one non-calcified lung nodule or any suspicious finding on CT scan characterised by focal [18F]FDG uptake deviating from physiological distribution or above physiological background activity. | Procedure or surgery | LDCT scan and simultaneous [18F]FDG PET/CT on new-generation long axial field of view scanner |
| LDTC onlyThe LDCT scan will be performed in single deep inspiratory breath hold. No intravenous contrast will be administered. | Procedure or surgery | low LDCT only |
Primary outcome
The primary objective is to assess the diagnostic accuracy of low-dose [18F]FDG PET/CT for screening in high-risk individuals or lung cancer Time Frame:
Time frame: 24 months
The primary endpoint is the detection rate of [18F]FDG PET/CT for suspicious lung nodules. The sensitivity, specificity and accuracy will be calculated by a per-patient and per-lesion analysis based on the clinico-radiological follow-up. PET/CT images will be considered positive if there is at least one non-calcified lung nodule or one suspicious finding on CT scan characterised by focal [18F]FDG uptake that deviates from the physiological distribution or is above the physiological background activity. If there are no areas of increased uptake compared to physiological background activity, PET/CT images are considered negative.
1 secondary outcome
Assessment of the diagnostic accuracy of LDCT alone for screening in high-risk individuals or lung cancer and accuracy of [18F]FDG PET/CT for the additional detection of non-lung cancers in a high-risk population.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LDCT scan and simultaneous [18F]FDG PET/CT on new-generation long axial field of view scanner and LDTC only in people with Lung Cancer Screening, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective is to assess the diagnostic accuracy of low-dose [18F]FDG PET/CT for screening in high-risk individuals or lung cancer Time Frame: (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024; AzTrials last refreshed its copy on 31 Oct 2026.