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Clinical Application of a Low-Dose CBCT AI Model

27. september 2026 oppdatert av: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Low-dose AI-reconstructed CBCT Versus Full-dose CBCT for Guidance of Interventional Procedures: a Multicenter Randomized Controlled Trial

Cone Beam CT (CBCT) is an imaging modality used in interventional digital subtraction angiography (DSA). It produces three-dimensional images via cone-beam X-ray scanning and computer reconstruction. Clinically, CBCT guides puncture for pulmonary and hepatic lesions and evaluates post-intervention outcomes in liver cancer and cerebrovascular diseases. However, CBCT-guided interventions carry high patient radiation exposure; dose reduction often degrades image quality and impairs procedural results. Studies report that each 100 mGy radiation increment elevates cancer risk by 1.96-fold.

Artificial intelligence enables low-dose CBCT. Our prior DeepPriorCBCT model embedded anatomical priors using neural discrete representation learning, reducing thoracic CBCT dose to one-sixth of routine protocols while preserving image quality. We further developed DeepPriorCBCT-V2 using 55 000 pre-reconstruction CBCT datasets covering brain, thorax and abdomen. This multi-organ model maintains image quality at one-sixth standard radiation dose. Nevertheless, its real-world clinical performance remains unvalidated. We therefore designed this prospective multicenter randomized controlled trial to evaluate the clinical applicability of DeepPriorCBCT-V2.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

1380

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Anhui
      • Hefei, Anhui, Kina
        • Rekruttering
        • The First Affiliated Hospital of University of Science and Technology of China
        • Ta kontakt med:
    • Hubei
      • Wuhan, Hubei, Kina, 430022
        • Rekruttering
        • Wuhan Union Hospital
        • Ta kontakt med:
      • Wuhan, Hubei, Kina, 430022
        • Rekruttering
        • Wuhan Union West Hospital
        • Ta kontakt med:
      • Wuhan, Hubei, Kina, 430022
        • Rekruttering
        • Wuhan Union Jinyin Lake Hospital
        • Ta kontakt med:
    • Jiangsu
      • Nanjing, Jiangsu, Kina
        • Rekruttering
        • Zhongda Hospital, Medical School, Southeast University
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Age ≥18 years.

    • Requires CBCT-guided interventional treatment or surgery (e.g., cerebral angiography, lung puncture biopsy, hepatic artery chemoembolization, or percutaneous liver biopsy) and meets operational indications.

      • Can understand the study's purpose, procedures, potential risks, and benefits, and voluntarily signs a written informed consent form.

Exclusion Criteria:

  • History of high-dose radiation exams or treatments.

    • Known allergies or severe adverse reactions to iodine contrast agents or other relevant medications.

      • Pregnant or breastfeeding women.

        • Severe comorbidities or chronic diseases (e.g., severe diabetes, renal insufficiency).

          • Severe mental illness or cognitive impairment preventing understanding of the study procedures or providing informed consent.

            ⑥ Participants are not suitable for the trial per investigator's opinion.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Participants will receive interventional procedures guided by DeepPriorCBCT-V2.

Patients underwent interventional procedures guided by CBCT images reconstructed via the DeepPriorCBCT-V2 model from low-radiation-dose scans (1/6 of the conventional dose for the thorax and abdomen, and 1/5 for the brain).
Annen: DeepPriorCBCT-V2

Compared with conventional CBCT-guided interventional procedures and previously reported low-dose CBCT studies, the intervention adopted in the present study has several distinct advantages. First, most existing low-dose CBCT protocols only reduce radiation for a single anatomical region, mainly the thorax, while our DeepPriorCBCT-V2 model achieves stable low-dose reconstruction for the brain, thorax, and abdomen simultaneously, with radiation reduced to 1/6 of the standard clinical level for the thorax and abdomen and 1/5 for the brain. Second, unlike general noise-reduction algorithms used in previous studies, our model embeds anatomical prior information through neural discrete representation learning, which ensures consistent and reliable image quality at extremely low radiation doses without sacrificing intraoperative guidance accuracy. Third, this study is the first prospective multicenter randomized controlled trial to systematically verify the clinical feasibility of multi-orga
Placebo komparator: Participants will receive interventional procedures guided by clinical standard protocol.

Patients underwent interventional procedures guided by CBCT images reconstructed via clinical standard protocol (full-radiation-dose).
Enhet: Clinical standard protocol (Full-radiation-dose CBCT)

Interventional procedures were performed under the guidance of clinical standard protocol (Full-radiation-dose CBCT).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Radiation dose
Tidsramme: Through study completion, an average of 5 months.

Air Kerma (AK) refers to the sum of the initial kinetic energies transferred from uncharged ionizing radiation (such as X-ray photons) to charged particles in air, divided by the mass of air at that location.
Through study completion, an average of 5 months.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Operation time
Tidsramme: Through study completion, an average of 5 months.

The time from the initiation to the completion of the interventional procedure.
Through study completion, an average of 5 months.
Intraoperative complications.
Tidsramme: Through study completion, an average of 5 months.

Procedure-related intraprocedural complications.
Through study completion, an average of 5 months.
Post operative complications
Tidsramme: Through study completion, an average of 5 months.

Procedure-related complications within 7 days after the interventional procedure.
Through study completion, an average of 5 months.

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Subjective scoring
Tidsramme: Through study completion, an average of 5 months.

Scoring of reconstructed CBCT images was performed by radiologists and interventional physicians using a 5-point Likert scale. The scale was defined as: 1 = very poor image quality; lesions cannot be assessed and the procedure cannot be guided; 2 = poor image quality; lesion assessment and procedure guidance are difficult; 3 = moderate image quality; lesion assessment is relatively difficult, but procedure guidance is feasible; 4 = good image quality; lesions can be assessed and procedure guidance is achievable; 5 = excellent image quality; lesion assessment is not compromised at all and procedure guidance is fully supported.
Through study completion, an average of 5 months.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. august 2026

Primær fullføring (Antatt)

30. november 2026

Studiet fullført (Antatt)

31. desember 2026

Datoer for studieregistrering

Først innsendt

21. september 2026

Først innsendt som oppfylte QC-kriteriene

27. september 2026

Først lagt ut (Faktiske)

29. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • DeepPriorCBCT-V2

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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