Lung NodulesNCT07035977
DeepPriorCBCT for Low Dose Lung CBCT Reconstruction
A study testing Participants will receive a 1/6 views undersampling lung CBCT scan. in people with Lung Nodules, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 5 sites in China.
Trial summary
The goal of this clinical trial is to learn if the DeepPriorCBCT model ensure high-quality CBCT image while reducing CBCT radiation dose. The main questions it aims to answer are: Can DeepPriorCBCT reduce CBCT radiation doses? Is the image quality of DeepPriorCBCT reconstruction consistent with that of existing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Nodules
- What is being tested?
- Participants will receive a 1/6 views undersampling lung CBCT scan.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 5 sitesChina
- Study dates
- 15 May 2025to 20 Jul 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will receive percutaneous thoracic puncture under the guidance of CBCT during the study period.
- The participants' medical records containing basic information, medical history, etc are complete.
- Participants can understand the study's purpose, procedures, potential risks, and benefits, and voluntarily signs a written informed consent form.
Who cannot join
- Participants are under the age of 18.
- Participants are suffering from severe mental illness or cognitive impairment, unable to understand the study and sign.
- Participants are pregnant or breastfeeding women.
- Participants are concurrent participating in other programs that affect the results of this study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Wuhan Union Hospital
Wuhan, Hubei, 430022
Wuhan Union Jinyin Lake Hospital
Wuhan, Hubei, 430022
Wuhan Union West Hospital
Wuhan, Hubei, 430022
The First Affiliated Hospital East Campus of Zhengzhou University
Zhengzhou, Henan
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: A Deep-learning System for Low-Dose CBCT Image Reconstruction: a Stepwise, Multicentre, Early-stage Clinical Validation Study
The goal of this clinical trial is to learn if the DeepPriorCBCT model ensure high-quality CBCT image while reducing CBCT radiation dose. The main questions it aims to answer are:
- Can DeepPriorCBCT reduce CBCT radiation doses?
- Is the image quality of DeepPriorCBCT reconstruction consistent with that of existing clinical reconstruction method? Researchers will compare CBCT images quality reconstruction with DeepPriorCBCT model to CBCT image quality reconstruction with existing clinical protocols to see if DeepPriorCBCT model can improve the CBCT image quality while reducing radiation dose.
Read more
Participants will:
- Receive a single low dose (1/6 of existing clinical protocols) CBCT scan
- Receive a single conventional dose CBCT scan
- Conditions
- Lung Nodules
- Being tested
- Participants will receive a 1/6 views undersampling lung CBCT scan.
- Keywords
- DeepPriorCBCT, Lung nodules, Low dose radiation, Cross-Over Observational Study, CBCT, Percutaneous thoracic biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants will receive a 1/6 views undersampling lung CBCT scan.Radiation
Participants will receive a 1/6 views undersampling lung CBCT scan. And the CBCT images will be reconstructed by DeepPriorCBCT model for further analysis.
| Study group | Role | What they receive |
|---|---|---|
| Participants will receive a 1/6 views undersampling lung CBCT scan. | Experimental | Participants will receive a 1/6 views undersampling lung CBCT scan. And the CBCT images will be reconstructed by DeepPriorCBCT model for further analysis. Receives: Radiation: Participants will receive a 1/6 views undersampling lung CBCT scan. |
| Participants will receive a full-sampling lung CBCT scan. | No intervention | Participants will receive a full-sampling lung CBCT scan. And the CBCT images will be reconstructed by current clinical method for further analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CBCT Images Quality Score
CBCT Images Quality Score was analyzed by 5 radiologists using 5-point Likert scale.
Measured: No more than 1 week
Secondary outcomes (3)
The scores of lesion diagnosis from 5 radiologists
5 radiologists from 5 medical centers will be invited to diagnosis the lesion of fully sampled machine-reconstructed CBCT images vs. undersampled model-reconstructed CBCT images.
Measured: No more than 1 week
The agreement scores given by the 25 interventionalists.
25 interventionalists from 5 medical centers will be invited to analyze fully sampled machine-reconstructed CBCT images vs. undersampled model-reconstructed CBCT images. The scores given by the 25 interventionalists will be used for agreement score analysis.
Measured: No more than 1 week.
Radiation dose
Radiation dose is defined as the radiation dose received by patients when undergoing one conventional-dose CBCT scan and one undersampled CBCT scan.
Measured: No more than 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start15 May 2025
- Primary completion15 Jul 2025
- Study completion20 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung NodulesStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07035977
- Sponsor's protocol ID
- DeepPriorCBCT001
- Status last verified
- Dec 2025
- First submitted
- 17 Jun 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bosch de Basea M, Thierry-Chef I, Harbron R, Hauptmann M, Byrnes G, Bernier MO, Le Cornet L, Dabin J, Ferro G, Istad TS, Jahnen A, Lee C, Maccia C, Malchair F, Olerud H, Simon SL, Figuerola J, Peiro A, Engels H, Johansen C, Blettner M, Kaijser M, Kjaerheim K, Berrington de Gonzalez A, Journy N, Meulepas JM, Moissonnier M, Nordenskjold A, Pokora R, Ronckers C, Schuz J, Kesminiene A, Cardis E. Risk of hematological malignancies from CT radiation exposure in children, adolescents and young adults. Nat Med. 2023 Dec;29(12):3111-3119. doi: 10.1038/s41591-023-02620-0. Epub 2023 Nov 9.
PubMed 37946058Mazzone PJ, Lam L. Evaluating the Patient With a Pulmonary Nodule: A Review. JAMA. 2022 Jan 18;327(3):264-273. doi: 10.1001/jama.2021.24287.
PubMed 35040882
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Deep-learning System for Low-Dose CBCT Image Reconstruction: a Stepwise, Multicentre, Early-stage Clinical Validation Study
- ClinicalTrials.gov ID
- NCT07035977
- Acronym / sponsor ID
- DeepPriorCBCT001
- Conditions
- Lung Nodules
- Keywords
- DeepPriorCBCT, Lung nodules, Low dose radiation, Cross-Over Observational Study, CBCT, Percutaneous thoracic biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 25 Jun 2025 (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.
The goal of this clinical trial is to learn if the DeepPriorCBCT model ensure high-quality CBCT image while reducing CBCT radiation dose. The main questions it aims to answer are:
- Can DeepPriorCBCT reduce CBCT radiation doses?
- Is the image quality of DeepPriorCBCT reconstruction consistent with that of existing clinical reconstruction method? Researchers will compare CBCT images quality reconstruction with DeepPriorCBCT model to CBCT image quality reconstruction with existing clinical protocols to see if DeepPriorCBCT model can improve the CBCT image quality while reducing radiation dose.
Participants will:
- Receive a single low dose (1/6 of existing clinical protocols) CBCT scan
- Receive a single conventional dose CBCT scan
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants will receive a 1/6 views undersampling lung CBCT scan. | Experimental | Radiation: Participants will receive a 1/6 views undersampling lung CBCT scan.Participants will receive a 1/6 views undersampling lung CBCT scan. And the CBCT images will be reconstructed by DeepPriorCBCT model for further analysis. |
| Participants will receive a full-sampling lung CBCT scan. | No intervention | –Participants will receive a full-sampling lung CBCT scan. And the CBCT images will be reconstructed by current clinical method for further analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants will receive percutaneous thoracic puncture under the guidance of CBCT during the study period.
- The participants' medical records containing basic information, medical history, etc are complete.
- Participants can understand the study's purpose, procedures, potential risks, and benefits, and voluntarily signs a written informed consent form.
Key exclusion criteria (4 listed)
- Participants are under the age of 18.
- Participants are suffering from severe mental illness or cognitive impairment, unable to understand the study and sign.
- Participants are pregnant or breastfeeding women.
- Participants are concurrent participating in other programs that affect the results of this study.
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 |
|---|---|---|
| Participants will receive a 1/6 views undersampling lung CBCT scan.Participants will receive a 1/6 views undersampling lung CBCT scan. And the CBCT images will be reconstructed by DeepPriorCBCT model for further analysis. | Radiation | Participants will receive a 1/6 views undersampling lung CBCT scan. |
Primary outcome
CBCT Images Quality Score
Time frame: No more than 1 week
CBCT Images Quality Score was analyzed by 5 radiologists using 5-point Likert scale.
3 secondary outcomes
The scores of lesion diagnosis from 5 radiologists
Time frame: No more than 1 week
The agreement scores given by the 25 interventionalists.
Time frame: No more than 1 week.
Radiation dose
Time frame: No more than 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Results publication: PubMed 37946058Bosch de Basea M, Thierry-Chef I, Harbron R, Hauptmann M, Byrnes G, Bernier MO, Le Cornet L, Dabin J, Ferro G, Istad TS, Jahnen A, Lee C, Maccia C, Malchair F, Olerud H, Simon SL, Figuerola J, Peiro A, Engels H, Johansen C, Blettner M, Kaijser M, Kjaerheim K, Berrington de Gonzalez A, Journy N, Meulepas JM, Moissonnier M, Nordenskjold A, Pokora R, Ronckers C, Schuz J, Kesminiene A, Cardis E. Risk of hematological malignancies from CT radiation exposure in children, adolescents and young adults. Nat Med. 2023 Dec;29(12):3111-3119. doi: 10.1038/s41591-023-02620-0. Epub 2023 Nov 9.
- Results publication: PubMed 35040882Mazzone PJ, Lam L. Evaluating the Patient With a Pulmonary Nodule: A Review. JAMA. 2022 Jan 18;327(3):264-273. doi: 10.1001/jama.2021.24287.
- Individual participant dataSharing planned: No
Related trials for Lung Nodules
Recruiting
Longitudinal AI-Assisted Management of Indeterminate Pulmonary Nodules
Pulmonary Nodules, Lung Neoplasms
Active, not recruitingObservational study
Clinical Application of Artificial Intelligence Methods in Diagnostic Imaging of Pulmonary Nodules
Pulmonary Nodules, Lung Neoplasms
RecruitingObservational study
Lung Cancer Detection in Never Smokers Using Urine Volatile Organic Compound (VOCs)
Lung Cancer
RecruitingObservational study
Study of Collection and Analysis of Clinical, Anamnestic, Functional, Biological Data Through the Support of Artificial Intelligence to Evaluate the Possibility of Defining a Digital Twin of the Lung (LUCE)
Thoracic Neoplasm, Pulmonary Nodules
Not yet recruitingPhase 4
Preoperative Pneumococcal and Influenza Vaccination to Prevent Postoperative Pulmonary Infection in Patients Undergoing Lung Resection for Pulmonary Nodules or Lung Cancer
Pneumococcal Polysaccharide Vaccine, Influenza Vaccines
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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participants will receive a 1/6 views undersampling lung CBCT scan. in people with Lung Nodules, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 5 sites in China.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CBCT Images Quality Score (time frame: No more than 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07035977, which also lists 2 linked publications.
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 18 Dec 2025.