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Spontaneous Intracerebral HemorrhageNCCT-DL-HENCT06602115

Noncontrast CT-Based Deep Learning for Predicting Hematoma Expansion Risk in Patients with Spontaneous Intracerebral Hemorrhage

An observational study of Spontaneous Intracerebral Hemorrhage and Hematoma Expansion, run by Qiang Yu at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Hematoma expansion is an independent predictor of poor prognosis and early neurological deterioration in patients with spontaneous intracerebral hemorrhage. Early identification of high-risk patients and timely targeted medical interventions may provide a crucial opportunity to limit hematoma growth and improve… Read more about this study

Who is it for?
Ages 18 years and older
How many people
2,000 participants
Where
1 siteChina
Study dates
25 Sep 2024to Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: A multicenter retrospective cohort of 2000 patients with spontaneous intracerebral hemorrhage, including 500 cases of hematoma expansion and 1500 cases without hematoma expansion.

Who may be able to join

  • Primary, spontaneous (non-traumatic) intracerebral hemorrhage (ICH).
  • Age ≥ 18 years.
  • Baseline CT performed within 24 hours of ICH symptom onset or last seen well (LSW).
  • Follow-up CT within 72 hours.

Who cannot join

  • Secondary ICH caused by trauma, vascular anomalies (e.g., aneurysm, cavernous angioma, arteriovenous malformation), brain tumor, or hemorrhagic transformation in brain infarction.
  • Primary intraventricular hemorrhage (IVH).
  • Surgical treatment with external ventricular drain placement or craniotomy.
  • Obvious artifacts observed in CT images.

Trial locations and contacts

1 site in 1 country.

China1 site
  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

    Qiang Dr.Yu, MD, +86 23 15023340201, yuqiang0915@126.com

Other trials in China

About this study

Hematoma expansion is an independent predictor of poor prognosis and early neurological deterioration in patients with spontaneous intracerebral hemorrhage. Early identification of high-risk patients and timely targeted medical interventions may provide a crucial opportunity to limit hematoma growth and improve neurological outcomes. This study aims to develop an end-to-end deep learning model based on noncontrast computed tomography images to predict the risk of hematoma expansion in patients with spontaneous intracerebral hemorrhage. This model could serve as a valuable risk stratification tool for patients with hematoma expansion, facilitating targeted treatment and providing clinicians with streamlined decision-making support in emergency situations.

Read the detailed description

This project is planned to be implemented in four steps:

  1. Data Collection
  2. Selection of Study Subjects: Clinical and imaging data of patients with spontaneous intracerebral hemorrhage were retrospectively collected from multiple centers, including 500 cases in the hematoma expansion group and 1500 cases in the non-expansion group, totaling 2000 cases. Hematoma expansion (rHE) was defined as an absolute increase in ICH volume of ≥6 mL or a relative increase of ≥33%.
  3. Collection of Clinical Data: Includes patient age, gender, history of coronary heart disease, smoking, alcohol, hypertension, admission systolic and diastolic blood pressures, among others.
  4. CT Image Acquisition: Admission and follow-up CT images were obtained using spiral CT scanning with a slice thickness and interslice spacing of 5 mm.
  5. Segmentation of Hematoma Based on Non-contrast CT Images Two radiologists independently segmented the volume of interest of the entire brain hematoma lesion using ITK-SNAP software, manually outlining the lesion on each CT slice while avoiding the surrounding edema and normal brain tissue.
  6. Establishment of Automatic Hematoma Segmentation Model
  7. Data Acquisition and Preprocessing: All images were obtained through the PACS system and stored in DICOM format. Standardized preprocessing steps were applied, including image resampling, window width, and window level adjustments to accommodate parameter differences across different CT scanners.
  8. Selection of Automatic Segmentation Model: Suitable deep learning architectures for segmentation were explored and selected, including encoder-decoder structures such as nnU-Net, UNETR, and nnFormer. The optimal image segmentation model was chosen to achieve precise segmentation of brain hematoma regions.
  9. Model Training and Evaluation: The model was trained using supervised learning, with manually segmented masks from the annotated dataset serving as ground truth labels. Model performance was evaluated on validation and independent external test sets using metrics such as Dice coefficient, Intersection over Union (IoU), precision, and recall.
  10. Establishment of Automatic Classification Model for Hematoma Expansion
  11. Construction of the Automatic Classification Model: Based on the segmentation masks extracted by the automatic segmentation model, a deep learning classification model was developed to predict hematoma expansion. Various 2D and 3D classification neural networks, including 2D-ResNet-101, 2D-ViT, 3D-ResNet-101, and 3D-ViT, were developed. Using the 3D masks generated by automatic segmentation, the largest 2D rectangular region of interest and the smallest 3D bounding box of the brain hematoma were cropped from the original CT images, and these cropped regions were input into the corresponding deep learning classification models to achieve precise prediction of hematoma expansion.
  12. Visualization of the Automatic Classification Model: To visually verify the decision-making process of the deep learning model, Gradient-weighted Class Activation Mapping (Grad-CAM) technology was used to generate 2D attention maps, visually displaying the key hematoma regions identified by the model for classification.
  13. Model Training and Evaluation: During model evaluation, the performance of the model was tested using an independent external test set, with comprehensive evaluation metrics including accuracy, sensitivity, specificity, F1 score, ROC curve, and AUC value. This process aimed to validate the model\'s generalizability and robustness across multicenter data, ensuring its reliability and effectiveness in actual clinical applications.
Being tested
Observational study, no interventions involved
Keywords
Spontaneous Intracerebral Hemorrhage, Hematoma Expansion, Deep Learning

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Observational study, no interventions involvedOther

    Observational study, no interventions involved

Study groups in NCT06602115
Study groupRoleWhat they receive
Hematoma Expansion GroupHematoma Expansion Group
Receives: Other: Observational study, no interventions involved
No Hematoma Expansion GroupPatients without hematoma expansion as defined in the study
Receives: Other: Observational study, no interventions involved

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prediction of Hematoma Expansion

    Proportion of patients with hematoma expansion

    Measured: From the onset of ICH symptoms to 72 hours after baseline CT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start25 Sep 2024 (estimated)
  3. Primary completionOct 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06602115
Sponsor's protocol ID
K2023-138
Other IDs
K2023-138
Acronym
NCCT-DL-HE
Status last verified
Aug 2024
First submitted
10 Sep 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Tran AT, Zeevi T, Haider SP, Abou Karam G, Berson ER, Tharmaseelan H, Qureshi AI, Sanelli PC, Werring DJ, Malhotra A, Petersen NH, de Havenon A, Falcone GJ, Sheth KN, Payabvash S. Uncertainty-aware deep-learning model for prediction of supratentorial hematoma expansion from admission non-contrast head computed tomography scan. NPJ Digit Med. 2024 Feb 6;7(1):26. doi: 10.1038/s41746-024-01007-w.

    PubMed 38321131

Questions about this trial

What is this clinical trial studying?

An observational study of Spontaneous Intracerebral Hemorrhage and Hematoma Expansion, run by Qiang Yu at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Qiang Dr.Yu, MD (+86 23 15023340201, yuqiang0915@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prediction of Hematoma Expansion (time frame: From the onset of ICH symptoms to 72 hours after baseline CT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06602115, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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