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.
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
- Conditions the study is for
- Spontaneous Intracerebral Hemorrhage, Hematoma Expansion
- 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
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:
- Data Collection
- 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%.
- Collection of Clinical Data: Includes patient age, gender, history of coronary heart disease, smoking, alcohol, hypertension, admission systolic and diastolic blood pressures, among others.
- 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.
- 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.
- Establishment of Automatic Hematoma Segmentation Model
- 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.
- 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.
- 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.
- Establishment of Automatic Classification Model for Hematoma Expansion
- 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.
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| Hematoma Expansion Group | Hematoma Expansion Group Receives: Other: Observational study, no interventions involved | |
| No Hematoma Expansion Group | Patients 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.
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.
- First posted19 Sep 2024
- Study start25 Sep 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spontaneous Intracerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Qiang Yu
- Sponsor type
- University, hospital or other
- Collaborators
- Xiangya Hospital of Central South University, The First Affiliated Hospital with Nanjing Medical University, Southwest Hospital, China, Liuzhou Workers' Hospital
- Responsible party
- Sponsor-investigator, Qiang Yu, First Affiliated Hospital of Chongqing Medical University
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noncontrast CT-Based Deep Learning for Predicting Hematoma Expansion Risk in Patients with Spontaneous Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT06602115
- Acronym / sponsor ID
- NCCT-DL-HE / K2023-138
- Keywords
- Spontaneous Intracerebral Hemorrhage, Hematoma Expansion, Deep Learning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Qiang YuUniversity, hospital or other
- Collaborators
- Xiangya Hospital of Central South University, The First Affiliated Hospital with Nanjing Medical University, Southwest Hospital, China, Liuzhou Workers' Hospital
- Study start
- 25 Sep 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This project is planned to be implemented in four steps:
- Data Collection
- 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%.
- Collection of Clinical Data: Includes patient age, gender, history of coronary heart disease, smoking, alcohol, hypertension, admission systolic and diastolic blood pressures, among others.
- 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.
- 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.
- Establishment of Automatic Hematoma Segmentation Model
- 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.
- 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.
- 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.
- Establishment of Automatic Classification Model for Hematoma Expansion
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hematoma Expansion Group | – | Other: Observational study, no interventions involvedHematoma Expansion Group |
| No Hematoma Expansion Group | – | Other: Observational study, no interventions involvedPatients without hematoma expansion as defined in the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study, no interventions involvedObservational study, no interventions involved | Other | Hematoma Expansion Group, No Hematoma Expansion Group |
Primary outcome
Prediction of Hematoma Expansion
Time frame: From the onset of ICH symptoms to 72 hours after baseline CT
Proportion of patients with hematoma expansion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 38321131Tran 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.