Clinical trial NCT06762613: Functional Innovation and Application Research of Domestic Advanced Low-Dose DSA/CT-DSA
Official title: Enhancing CBCT-Guided Lung Nodule Puncture Efficiency With Generative AI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Nodules
Keywords: Generative AI
Lung puncture
Cone beam CT
DSA
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of puncture needles of participants for GPS and CBCT-guided lung puncture procedures.
timeFrame: From enrollment to the end of the lung puncture procedure.
Secondary outcomes:
measure: Radiation dose for GPS and CBCT-guided lung puncture procedures.
timeFrame: From enrollment to the end of the lung puncture procedure.
measure: Puncture time for GPS and CBCT-guided lung puncture procedures.
timeFrame: From enrollment to the end of the lung puncture procedure.
measure: Intraoperative and postoperative complications of participants for GPS and CBCT-guided lung puncture procedures.
timeFrame: From enrollment to the end of the lung puncture procedure at 1 week.
Other outcomes:
measure: Algorithmic performance (peak signal-to-noise ratio)
timeFrame: Through study completion, an average of three months.
measure: Algorithmic performance (structural similarity)
timeFrame: Through study completion, an average of 3 months.
measure: Doctors' scoring of image and lesion quality
timeFrame: Through study completion, an average of 3 months.
Locations:
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan Union Jinyinhu Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan Union West Hospital
state: Hubei
Study officials:
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.