NCT06762613

Brief Summary

The goal of this clinical trial is to learn if Generative AI Based Puncture Surgery Navigation System (GPS) can guide lung puncture in adults better. It will also learn about the quality improvement of cone beam CT (CBCT) by GPS. The main questions it aims to answer are:

  • Does GPS lower the number of punctures, radiation dose, and complications of participants undergo percutaneous lung puncture?
  • Does GPS improve the quality of CBCT images? Researchers will compare GPS to a conventional CBCT guided percutaneous lung puncture to see if GPS can improve the efficacy of lung puncture. Participants will:
  • Take the percutaneous lung puncture by the guidance of GPS or conventional CBCT (placebo)
  • The number of punctures, the success rate of the procedure, the radiation dose, intraoperative complications and postoperative complications at 7 days will be recorded
  • The images of CBCT will be collected

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2025

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

December 15, 2024

Last Update Submit

July 17, 2025

Conditions

Lung Nodules

Keywords

Generative AILung punctureCone beam CTDSA

Outcome Measures

Primary Outcomes (1)

  • Number of puncture needles of participants for GPS and CBCT-guided lung puncture procedures.

    The number of punctures was defined as the number of punctures performed throughout the percutaneous lung puncture procedure.

    From enrollment to the end of the lung puncture procedure.

Secondary Outcomes (3)

  • Radiation dose for GPS and CBCT-guided lung puncture procedures.

    From enrollment to the end of the lung puncture procedure.

  • Puncture time for GPS and CBCT-guided lung puncture procedures.

    From enrollment to the end of the lung puncture procedure.

  • Intraoperative and postoperative complications of participants for GPS and CBCT-guided lung puncture procedures.

    From enrollment to the end of the lung puncture procedure at 1 week.

Other Outcomes (3)

  • Algorithmic performance (peak signal-to-noise ratio)

    Through study completion, an average of three months.

  • Algorithmic performance (structural similarity)

    Through study completion, an average of 3 months.

  • Doctors' scoring of image and lesion quality

    Through study completion, an average of 3 months.

Study Arms (2)

GPS guided lung puncture

EXPERIMENTAL

Participants will receive percutaneous lung puncture under the guidance of GPS.

Combination Product: Generative AI Based Puncture Surgery Navigation System

CBCT guided lung puncture

PLACEBO COMPARATOR

Participants will receive percutaneous lung puncture under the guidance of cone beam CT.

Device: Cone beam CT

Interventions

Generative AI Based Puncture Surgery Navigation SystemCOMBINATION_PRODUCT

Participants will receive percutaneous lung puncture under the guidance of GPS.

GPS guided lung puncture
Cone beam CTDEVICE

Participants will receive percutaneous lung puncture under the guidance of cone beam CT.

CBCT guided lung puncture

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants who require CBCT-guided precutaneous lung puncture (PLP) and meet the clinical indications for the procedure.
  • Participants with pre-operation CT images available.
  • Participants whose physical condition is suitable for PLP.

You may not qualify if:

  • Participants have metallic implants in the body, which severely affects the image quality.
  • Participants with a history of allergy or serious adverse reactions to iodine contrast media or other related drugs.
  • Participants are pregnant or breastfeeding.
  • Participants are unwilling or unable to sign informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

Location

Wuhan Union Jinyinhu Hospital

Wuhan, Hubei, 430022, China

Location

Wuhan Union West Hospital

Wuhan, Hubei, 430022, China

Location

Related Publications (6)

  • Deng L, Ji Y, Huang S, Yang X, Wang J. Synthetic CT generation from CBCT using double-chain-CycleGAN. Comput Biol Med. 2023 Jul;161:106889. doi: 10.1016/j.compbiomed.2023.106889. Epub 2023 Apr 3.

    PMID: 37244147RESULT

  • Ren Q, Zhou Y, Yan M, Zheng C, Zhou G, Xia X. Imaging-guided percutaneous transthoracic needle biopsy of nodules in the lung base: fluoroscopy CT versus cone-beam CT. Clin Radiol. 2022 May;77(5):e394-e399. doi: 10.1016/j.crad.2022.02.005. Epub 2022 Feb 25.

    PMID: 35227506RESULT

  • Choo JY, Park CM, Lee NK, Lee SM, Lee HJ, Goo JM. Percutaneous transthoracic needle biopsy of small (</= 1 cm) lung nodules under C-arm cone-beam CT virtual navigation guidance. Eur Radiol. 2013 Mar;23(3):712-9. doi: 10.1007/s00330-012-2644-6. Epub 2012 Sep 14.

    PMID: 22976917RESULT

  • Rotolo N, Floridi C, Imperatori A, Fontana F, Ierardi AM, Mangini M, Arlant V, De Marchi G, Novario R, Dominioni L, Fugazzola C, Carrafiello G. Comparison of cone-beam CT-guided and CT fluoroscopy-guided transthoracic needle biopsy of lung nodules. Eur Radiol. 2016 Feb;26(2):381-9. doi: 10.1007/s00330-015-3861-6. Epub 2015 Jun 6.

    PMID: 26045345RESULT

  • Steiling K, Kathuria H, Echieh CP, Ost DE, Rivera MP, Begnaud A, Celedon JC, Charlot M, Dietrick F, Duma N, Fong KM, Ford JG, Gould MK, Holguin F, Perez-Stable EJ, Tanner NT, Thomson CC, Wiener RS, Wisnivesky J. Research Priorities for Interventions to Address Health Disparities in Lung Nodule Management: An Official American Thoracic Society Research Statement. Am J Respir Crit Care Med. 2023 Mar 15;207(6):e31-e46. doi: 10.1164/rccm.202212-2216ST.

    PMID: 36920066RESULT

  • 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: 35040882RESULT

MeSH Terms

Interventions

Cone-Beam Computed Tomography

Intervention Hierarchy (Ancestors)

Tomography, X-Ray ComputedTomography, X-RayRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2024

First Posted

January 7, 2025

Study Start

January 1, 2025

Primary Completion

March 31, 2025

Study Completion

June 18, 2025

Last Updated

July 23, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)