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Status unknownNCT06602115NCCT-DL-HEUpdated Sep 19, 2024

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

An observational study in Spontaneous Intracerebral Hemorrhage and Hematoma Expansion, sponsored by Qiang Yu. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Qiang Yu · Observational

The sponsor has not verified this record recently (last verified Aug 2024), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
01

Study 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 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

  1. 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%.
  2. Collection of Clinical Data: Includes patient age, gender, history of coronary heart disease, smoking, alcohol, hypertension, admission systolic and diastolic blood pressures, among others.
  3. 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.

2. 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.

3. Establishment of Automatic Hematoma Segmentation Model

  1. 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.
  2. 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.
  3. 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.

4. Establishment of Automatic Classification Model for Hematoma Expansion

  1. 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.
  2. 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.
  3. 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.
02

Conditions studied

  • Spontaneous Intracerebral Hemorrhage
  • Hematoma Expansion

Keywords

  • Spontaneous Intracerebral Hemorrhage
  • Hematoma Expansion
  • Deep Learning
03

In context

Cerebral Hemorrhage

457 studies on the registry are indexed under Cerebral Hemorrhage; 172 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 300 across 180 observational studies indexed under Cerebral Hemorrhage.

Browse Cerebral Hemorrhage studies →

Lead sponsor

This is the only study on the registry with Qiang Yu as lead sponsor.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

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

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

Exclusion criteria

Exclusion Criteria:

  1. Secondary ICH caused by trauma, vascular anomalies (e.g., aneurysm, cavernous angioma, arteriovenous malformation), brain tumor, or hemorrhagic transformation in brain infarction.
  2. Primary intraventricular hemorrhage (IVH).
  3. Surgical treatment with external ventricular drain placement or craniotomy.
  4. Obvious artifacts observed in CT images.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
2,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Hematoma Expansion Group

    Hematoma Expansion Group

    Other: Observational study, no interventions involved

  • No Hematoma Expansion Group

    Patients without hematoma expansion as defined in the study

    Other: Observational study, no interventions involved

Interventions

  • OtherObservational study, no interventions involved

    Observational study, no interventions involved

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What researchers measure

Primary outcomes

  1. Prediction of Hematoma Expansion

    Proportion of patients with hematoma expansion

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

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Study locations

1 site
  • The First Affiliated Hospital of Chongqing Medical University
    Chongqing, Chongqing Municipality 400016, China
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06602115
Lead sponsor
Qiang Yu
Responsible party
Qiang Yu (Sponsor-Investigator, First Affiliated Hospital of Chongqing Medical University) — Sponsor-investigator
First posted
Sep 19, 2024
Start date
Sep 25, 2024 (estimated)
Primary completion
Oct 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Sep 19, 2024

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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