Clinical Application of a Low-Dose CBCT AI Model
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Lei Chen
- Telefonnummer: 15971480677
- E-Mail: chan0812@126.com
Studienorte
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Anhui
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Hefei, Anhui, China
- Rekrutierung
- The First Affiliated Hospital of University of Science and Technology of China
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Kontakt:
- Tao Sun
- Telefonnummer: 18064075705
- E-Mail: 1393879727@qq.com
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Hubei
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Wuhan, Hubei, China, 430022
- Rekrutierung
- Wuhan Union Hospital
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Kontakt:
- Lei Chen
- Telefonnummer: 15971480677
- E-Mail: chan0812@126.com
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Wuhan, Hubei, China, 430022
- Rekrutierung
- Wuhan Union West Hospital
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Kontakt:
- Lei Chen
- Telefonnummer: 15971480677
- E-Mail: chan0812@126.com
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Wuhan, Hubei, China, 430022
- Rekrutierung
- Wuhan Union Jinyin Lake Hospital
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Kontakt:
- Lei Chen
- Telefonnummer: 15971480677
- E-Mail: chan0812@126.com
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Jiangsu
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Nanjing, Jiangsu, China
- Rekrutierung
- Zhongda Hospital, Medical School, Southeast University
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Kontakt:
- Jian Lu
- Telefonnummer: 15850654644
- E-Mail: lujian43307131@126.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
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Age ≥18 years.
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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.
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Exclusion Criteria:
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History of high-dose radiation exams or treatments.
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Known allergies or severe adverse reactions to iodine contrast agents or other relevant medications.
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Pregnant or breastfeeding women.
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Severe comorbidities or chronic diseases (e.g., severe diabetes, renal insufficiency).
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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.
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Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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). |
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 |
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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). |
Interventional procedures were performed under the guidance of clinical standard protocol (Full-radiation-dose CBCT). |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Radiation dose
Zeitfenster: 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.
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Operation time
Zeitfenster: Through study completion, an average of 5 months.
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The time from the initiation to the completion of the interventional procedure. |
Through study completion, an average of 5 months.
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Intraoperative complications.
Zeitfenster: Through study completion, an average of 5 months.
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Procedure-related intraprocedural complications. |
Through study completion, an average of 5 months.
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Post operative complications
Zeitfenster: Through study completion, an average of 5 months.
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Procedure-related complications within 7 days after the interventional procedure. |
Through study completion, an average of 5 months.
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Subjective scoring
Zeitfenster: 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.
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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- DeepPriorCBCT-V2
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