ClinicalTrials.gg
Not yet recruitingNCT07445152Updated Mar 3, 2026

Research on Construction and Verification of Multimodal Medical Imaging Large Model

An observational study in Liver Diseases, Gallbladder Diseases and Pancreatic Diseases, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-03.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
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Study summary

With the accumulation of multimodal clinical data such as medical imaging and electronic health records (EHRs), efficient utilization of multi-source information to achieve precise diagnosis and intelligent decision-making has become a core direction of medical artificial intelligence (AI). Although traditional unimodal algorithms have yielded outcomes in specific tasks, their inability to model the semantic correlations among imaging, textual, and laboratory data leads to insufficient stability and limited interpretability of diagnostic results, making it difficult to meet the needs of comprehensive decision-making in complex clinical scenarios.

In recent years, multimodal large models have demonstrated excellent cross-modal understanding and knowledge transfer capabilities in natural images and general vision-language tasks, providing a new paradigm for medical AI. However, direct application in medical scenarios still faces challenges: first, the medical semantic system differs significantly from general language models, hindering the accurate representation of disease characteristics and imaging details; second, the complex morphology of lesions and uneven sample distribution in medical data increase the difficulty of model generalization; third, clinical data involves privacy, so data security and ethical compliance serve as prerequisites for research.

The research on medical multimodal large models aims to integrate multi-source heterogeneous medical data, establish a unified semantic representation and reasoning mechanism, and realize full-process intelligent analysis including disease identification and lesion localization. This approach can not only improve the efficiency and accuracy of clinical diagnosis but also provide clinicians with interpretable and traceable auxiliary decision support, boasting broad application prospects.

Based on the hospital's clinical data resources and the research team's algorithmic foundation, this study intends to construct a multimodal large model system for medical imaging diagnosis, enabling closed-loop intelligent analysis from multimodal information fusion to diagnostic report generation. The research will strictly adhere to medical ethical standards, protect patients' right to information, right to privacy, and data security. Before the official launch of the project, ethical review must be passed, and relevant regulations shall be followed to ensure the unity of scientific research and ethics, laying a compliant foundation for subsequent clinical validation and promotion.

Read the detailed description

With the continuous accumulation of medical imaging, electronic health records (EHRs), and multimodal clinical data, how to efficiently leverage multi-source medical information to achieve precise diagnosis and intelligent decision-making has become a core direction in the development of medical artificial intelligence (AI). Although traditional unimodal algorithms (e.g., models based solely on CT, MRI, or ultrasound images) have yielded certain results in specific tasks, their inability to model semantic correlations among imaging, textual, and laboratory data often leads to insufficient stability and limited interpretability of diagnostic outcomes, making it difficult to meet the comprehensive decision-making needs of complex clinical scenarios.

In recent years, multimodal large language models (MLLMs) have demonstrated remarkable cross-modal understanding and knowledge transfer capabilities in natural image processing and general vision-language tasks, providing a new technical paradigm for medical AI. However, the direct application of such models in medical scenarios still faces multiple challenges: first, there are significant discrepancies between the medical semantic system and general language models, hindering the accurate representation of disease characteristics and imaging details; second, the complex morphology of lesions and imbalanced sample distribution in medical data increase the difficulty of model generalization; third, clinical data involves privacy-sensitive information, making data security and ethical compliance a prerequisite for research.

Research on medical multimodal large models aims to comprehensively utilize multi-source heterogeneous data-such as medical imaging (e.g., CT, MRI, X-ray), EHRs, and laboratory reports-to establish a unified semantic representation and reasoning mechanism, enabling end-to-end intelligent analysis including disease identification, lesion localization, report generation, and disease progression prediction. This research direction not only helps improve the efficiency and accuracy of clinical diagnosis but also provides clinicians with interpretable and traceable auxiliary decision support, boasting broad prospects for clinical application.

Based on the hospital's abundant clinical data resources and the research team's algorithm development foundation, this study intends to construct a multimodal large model system for medical imaging diagnosis, realizing a closed-loop intelligent analysis pipeline from multimodal information fusion to diagnostic report generation.

During the research implementation, strict adherence to medical ethical standards will be followed to fully protect patients' right to informed consent, privacy, and data security. To ensure the scientificity and compliance of the research design, this project must pass ethical review prior to its official launch. In accordance with relevant regulations including the Declaration of Helsinki, International Ethical Guidelines for Health-related Research Involving Humans, and Ethical Review Measures for Life Science and Medical Research Involving Humans, we will achieve the organic integration of scientific research and ethical principles, laying a compliant foundation for subsequent clinical validation and application promotion.

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Conditions studied

  • Liver Diseases
  • Gallbladder Diseases
  • Pancreatic Diseases
  • Artificial Intelligence (AI)
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In context

Liver Diseases

824 studies on the registry are indexed under Liver Diseases; 152 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 200 across 262 observational studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

he study population was composed of adult patients who met the preset inclusion criteria and were free of any exclusion criteria.

In terms of inclusion requirements, eligible patients were aged 18 years or older and had received imaging examinations including computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound at the hospital during the study period. The examination items were required to target the hepatobiliary and pancreatic system, which was the focus of the research. All enrolled patients needed to be equipped with at least complete imaging data and radiological diagnostic reports, with relevant medical record information serving as supplementary modalities. In addition, written informed consent must be obtained from the patients themselves or their legal representatives, who agreed that the de-identified data of the patients could be used for the validation of scientific research models. Finally, all case data of the selected patients had to pass strict qual

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients aged ≥ 18 years.
  • Patients who underwent imaging examinations (CT, MRI, ultrasound, etc.) at this hospital during the study period.
  • The examination items are consistent with the disease types or systems focused on by the study (hepatobiliary and pancreatic system).
  • Possess at least complete imaging data, radiological diagnostic reports, with relevant medical record information as supplementary modalities.
  • Patients and their legal representatives have signed an form, agreeing to the use of their de-identified data for scientific research model validation.

Exclusion criteria

Exclusion Criteria:

  • Patients who refuse to sign the form.
  • Cases with unassessable images due to severe motion artifacts, incomplete scanning, or equipment abnormalities.
  • Cases with severe deficiency of clinical data or failure to match with imaging data.
  • Cases with special pathological conditions or post-operative status (e.g., extensive resection, significant structural changes after radiotherapy) that affect the consistency of model analysis.
  • Data samples with privacy protection or legal risks.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Target follow-up
4 Weeks
Patient registry
Yes

Groups and cohorts

  • Group1:This study enrolled adult patients aged ≥ 18 years who underwent imaging examinations (includ
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What researchers measure

Primary outcomes

  1. Disease Diagnosis Task

    The primary outcome is the accuracy and reliability of the multimodal imaging diagnostic model in identifying and classifying target diseases compared with the gold standard of clinical diagnosis by senior radiologists.

    Time frame: From enrollment to the end of diagnosis at 3 days

  2. Lesion Localization and Segmentation Task

    It includes the model's performance in precise localization, contour segmentation and quantitative measurement of lesions, assessed by Dice similarity coefficient, IoU and localization error.

    Time frame: from enrollment to end of diagnosis up to 3 days

  3. Diagnostic Report Generation Task

    It evaluates the clinical validity, completeness, consistency and readability of automatically generated radiology reports relative to manual reports.

    Time frame: from enrollment to end of diagnosis up to 3 days

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Study locations

No study locations are listed for this record.

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References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — The decision not to share individual participant data (IPD) from this study is primarily based on ethical, privacy protection, and legal compliance considerations, as well as the inherent characteristics of the research data involved. First and foremost, the core data of this study includes de-identified imaging materials, radiological diagnostic reports, and associated medical records of patients, which are closely linked to personal health information. Despite the implementation of de-identification procedures during data collection and collation, there remains a potential risk of re-identifying individual participants if the data are shared without strict restrictions. Such a risk would violate the stipulations of relevant privacy protection laws and regulations, as well as the informed consent signed by the patients and their legal representatives. It should be emphasized that the informed consent clearly specifies that the de-identified data of participants is only used for the in

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.

Of 103 non-industry observational studies under Liver Diseases, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 124. This study's planned 12 months is below that.

Counting every sponsor, half of 117 studies reached it within 47 months; a quarter within 22 and three quarters within 120.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 9, 2026
First posted
Mar 3, 2026
StartEst.
Nov 15, 2026
Primary completionEst.
Nov 15, 2027
CompletionEst.
Nov 15, 2027
Last update
Mar 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07445152
Responsible party
Sponsor
First posted
Mar 3, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
Nov 15, 2027 (estimated)
Completion
Nov 15, 2027 (estimated)
Last update
Mar 3, 2026

Study contacts

ding Yuan, Doctor
Contact
dingyuan@zju.edu.cn
+86 18858101960

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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