DeepPriorCBCT for Low Dose Lung CBCT Reconstruction

NCT07035977 | Completed DMC

• 1 other identifier: DeepPriorCBCT001
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 5

Brief 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 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

Conditions

Lung Nodules

Keywords

DeepPriorCBCT; Lung nodules; Low dose radiation; Cross-Over Observational Study; CBCT; Percutaneous thoracic biopsy

Outcome Measures

Primary Outcomes (1)

• CBCT Images Quality Score

  CBCT Images Quality Score was analyzed by 5 radiologists using 5-point Likert scale.

  No more than 1 week

Secondary Outcomes (3)

• The scores of lesion diagnosis from 5 radiologists

  No more than 1 week

• The agreement scores given by the 25 interventionalists.

  No more than 1 week.

• Radiation dose

  No more than 1 day

Other Outcomes (1)

• Objective indicators for reconstructed CBCT images

  No more than 1 week.

Study Arms (2)

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.

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.

Interventions

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.

Participants will receive a 1/6 views undersampling lung CBCT scan.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (5)

The First Affiliated Hospital East Campus of Zhengzhou University

Zhengzhou, Henan, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

Location

Wuhan Union Jinyin Lake Hospital

Wuhan, Hubei, 430022, China

Location

Wuhan Union West Hospital

Wuhan, Hubei, 430022, China

Location

Related Publications (2)

• 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.

  PMID: 37946058 RESULT

• Mazzone 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.

  PMID: 35040882 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: May 15, 2025
• Primary Completion: July 15, 2025
• Study Completion: July 20, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)