Pancreatitis, ChronicRECURNCT05778929
Radiomic fEatures of Pancreas From Contrast Enhanced CT Image Predict One-Year RecUrrence Risk of Acute PancReatitis
An observational study of Pancreatitis, Chronic, run by Peking University People's Hospital.
Trial summary
One-year recurrence rate of acute pancreatitis at about 20%. 36% of the patients with recurrent acute pancreatitis will develop into chronic pancreatitis. In addition to negative impact on patient's quality of life, chronic pancreatitis is also associated with the occurrence of pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatitis, Chronic
- What is being tested?
- Radiomics Model
- How many people
- 694 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 1 Apr 2025
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subjects enrolled in this prospective study are adult patients diagnosed as the first onset of acute pancreatitis and recommended for enhanced pancreatic CT scan within 14 days after onset of symptoms and accepted follow-up via telephone or returning to the site at 1, 3, 6 and 12 months.
Who may be able to join
- 18 -70 years old
- The subject met the following three criteria and diagnosed with acute pancreatitis according to the Atlanta Classification of Acute Pancreatitis.
- 2.1 Abdominal pain indicative of pancreatitis 2.2 Serum levels of amylase or lipase >3 times the upper limit of normal 2.3 Characteristic findings from abdominal imaging (unenhanced CT\MR\ultrasonography)
- Referred for an enhanced CT examination with Iopromide 370 in 14 days after symptom onset by clinicians
- Sign the informed consent
Who cannot join
- Has history of allergy to iodinated contrast agent
- Confirmed or suspected hyperthyroidism or pheochromocytoma;
- Pregnant or lactating women
- Patients who are participating another clinical study
- Disturbance of consciousness
- Has a history of acute pancreatitis
Show all 12Show fewer
- Has acute attack of chronic pancreatitis
- Has a history of pancreatic surgery
- Has co-morbidities such as cancer or other severe chronic wasting diseases
- Has a history of other surgeries or surgical implants that affects imaging and quality of pancreatic imaging
- Typical indications for pancreatic surgery, gallbladder surgery or endoscopic retrograde cholangiopancreatography as judged by the clinician
- Any patient who is considered unsuitable for iodinated contrast agent-enhanced pancreatic CT scan at the discretion of the investigator
About this study
Official title: Radiomic fEatures of Pancreas From High-Concentration Contrast Enhanced CT Image Predict One-Year RecUrrence Risk of Acute PancReatitis: A Prospective, Multicenter Study
One-year recurrence rate of acute pancreatitis at about 20%. 36% of the patients with recurrent acute pancreatitis will develop into chronic pancreatitis. In addition to negative impact on patient's quality of life, chronic pancreatitis is also associated with the occurrence of pancreatic cancer. The etiology of recurrent acute pancreatitis (RAP) can be divided into mechanical obstructive factors (e.g. cholelithiasis, cholestasis), metabolic abnormality and toxic substance factors (e.g. hyperlipidemia and alcoholism), and other or idiopathic factors. At present, the diagnosis and treatment of RAP remains highly challenging. Early identification and intervention on risk factors of recurrence will be effective in reducing incidence and improving prognosis.
Contrast-enhanced Computed Tomography (CT) can not only provide more imaging information and further assess the severity of acute pancreatitis, but also aid in the differentiation of other diseases associated with acute abdominal pain. In addition, radiomics based on raw radiographic data has become a research hotspot in recent years. The purpose of this study is to establish and validate a deep learning model based on high concentration iopromide-enhanced abdominal CT images which is designed to predict the recurrence of pancreatitis in patients with first episode of pancreatitis within the 1-year follow-up period.
Read the detailed description
Primary objective(s) To evaluate the sensitivity and specificity of the deep-learning integrated model established with relevant clinical factors and radiomic features based on the high concentration (370 mgI/ml) Iopromide-enhanced pancreatic CT obtained within 14 days after the first onset of symptoms for quantitative prediction of (the first) recurrence of acute pancreatitis in 12 months follow-up period.
Sample Size:
According to previously published data, the average time of occurrence of RAP is 12.5 ± 3.6 months and one-year recurrence rate of acute pancreatitis is about 20%. In addition, the recurrence rate is estimated to be about 17% within the 12-month follow-up window in this study, when taking into account the clinical experience of our hospital.
The calculation parameters for sample size of the training set in the study are as follows:
- Z1-α/2 is1.96 at α=0.05
- L, the width of the acceptable 95% confidential interval of sensitivity or specificity, 0.03-0.1
- The sensitivity is 0.85, the specificity is 0.98, and the disease prevalence is 0.17 Calculated based on sensitivity, N1= 1.962X0.85 X (1-0.85)/0.12 X 0.17= 0.490/0.0017=288 Calculated based on specificity, N2=1.962X0.98 X (1-0.98)/0.12 X (1-0.17) = 0.075/0.008=61 The sample size of the training set is 288 x 1.2 = 346 considering a dropout rate of 20% in the study.
The training set, test set and validation set are estimated in a ratio of 5:2:3. The total sample size for this prospective study is 694. According to the order of patient enrollment, the last 200 patients recruited will form the validation set.
Statistical Analyses:
At baseline and follow-up, descriptive statistics will be used to describe the entire population and subgroups of interest. Summary statistics such as mean, median, standard deviation and range will be used to describe continuous variables. Categorical variables will be presented in a frequency table.
- Primary endpoint analysis For patients with acute pancreatitis undergoing enhanced CT scan, the model that used the combination of radiomics and clinical features is used to predict the recurrence probability of acute pancreatitis within 12 months. The sensitivity and specificity of prediction and corresponding 95% CI are calculated.
- Secondary endpoint analysis Chi-square testing for all potential clinical risk factors included (as described in the Chapter on Variables and Criteria Used in Determining Primary Endpoints). The variables with p< 0.05 are analyzed for multivariate logistic regression and clinical modeling. Also based on the logistic regression model, a combination model of radioomic features and clinical factors is established.
The sensitivity, specificity and corresponding 95% CI for prediction of recurrence within 1, 3, 6 and 12 months are calculated based on the model that used both clinical features and/or radiomics features. Only the first recurrence is calculated.
Brief statistics of the quality of CT images will be provided.
- Baseline demographic characteristics Demographic and baseline characteristics will be summarized descriptively. Sensitivity= TP/(TP+FN) Specificity=TN/(TN+FP) Accuracy = (TP+TN)/(TP+FN+TN+FP) TP=True positive TP=True negative FN=False negative FP=False positive TP+FN+TN+FP=Total number of patients Statistical analyses are performed using R software (R Core Team, Vienna, Austria) version 3.4.3 All tests are two-sided. A P value < 0.05 is considered statistically significant.
All therapies will be coded using the World Health Organization - Drug Dictionary (WHO-DD). Medical history and any disease will be coded using the most current version of ICH Medical Dictionary for Regulatory Activities (MedDRA).
- Conditions
- Pancreatitis, Chronic
- Being tested
- Radiomics Model
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiomics ModelDiagnostic test
A total of 694 consecutive eligible patients with first episode of "acute pancreatitis" that recommended for iopromide 370 mgI/ml enhanced pancreatic CT scan within 14 days after onset of symptoms (the sample size ratio of training set: test set: validation set is 5:2:3) will be sequentially enrolled at 10 sites (This study is observational in nature. The routine enhanced pancreatic CT protocol at all selected sites is similar or equivalent to that used in the PI site in the study).
Relevant clinical information of the enrolled subjects is collected. Radiomics features are extracted from the selected regions of interest on pancreatic CT images and classified. The subjects are followed up for 12 months and divided into recurrent group and non-recurrent group according to the first recurrence status.
| Study group | Role | What they receive |
|---|---|---|
| patients diagnosed as recurrent acute pancreatitis in 12 month | Recurrent acute pancreatitis: relapse occurs more than three months after the previous episode ended, with the exclusion of re-hospitalization due to local or systemic complications of the initial episode and chronic pancreatitis. Receives: Diagnostic Test: Radiomics Model | |
| patients not diagnosed as recurrent acute pancreatitis in 12 months | No relapse occurs more than three months after the previous episode ended, with the exclusion of re-hospitalization due to local or systemic complications of the initial episode and chronic pancreatitis. Receives: Diagnostic Test: Radiomics Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and specificity of the model established with relevant clinical factors and radiomic features
Image acquisition at each site is performed by an independent radiologist with ≥ 5 years of work experience. Radiomics features will be extracted from 370 mgI/ml Iopromide-enhanced pancreatic CT obtained within 14 days after the first onset of symptoms to quantitative predict the first recurrence of acute pancreatitis in 12 months follow-up period.Sensitivity= TP/(TP+FN) Specificity=TN/(TN+FP) Accuracy = (TP+TN)/(TP+FN+TN+FP) TP=True positive TP=True negative FN=False negative FP=False positive TP+FN+TN+FP=Total number of patients.
Measured: 12 months
Secondary outcomes (5)
The total number of subjects who developed the first recurrence of acute pancreatitis (subjects with multiple recurrences, calculated and analyzed according to the time of the earliest recurrence) within 3, 6 and 12 months
Recurrent acute pancreatitis: relapse occurs more than three months after disappearance of symptoms of the first episode, with the exclusion of re-hospitalization due to local or systemic complications of the initial episode and chronic pancreatitis.
Measured: in 12 months follow up period
The sensitivity and specificity of the deep-learning integrated model established with relevant clinical factors and radiomic features to quantitative predict overall recurrence of acute pancreatitis in 3 and 6 months follow-up period;
Sensitivity= TP/(TP+FN) Specificity=TN/(TN+FP) Accuracy = (TP+TN)/(TP+FN+TN+FP) TP=True positive TP=True negative FN=False negative FP=False positive
Measured: 3 months, 6 months
The image quality of Iopromide-enhanced pancreatic CT images obtained within 14 days after onset of symptoms
The Imaging Department, Peking University People's Hospital served as quality control center. Objective quantitative evaluation and subjective evaluation of the quality of the images from all sites are performed by two radiologists with ≥ 10 years of abdominal imaging experience. A 4-point scale is used for subjective evaluation of the overall image quality in terms of noise, sharpness and contrast. Where, a score of 0 denotes poor image quality; 1 denotes fair image quality; 2 denotes good image quality; 3 denotes excellent image quality. The images with a score of 2 to 3 are classified into the high-quality image set.
Measured: 14 days
The sensitivity and specificity of the model determined by radiomics features extracted from images with high quality scores (2-3 points)
Sensitivity= TP/(TP+FN) Specificity=TN/(TN+FP) Accuracy = (TP+TN)/(TP+FN+TN+FP) TP=True positive TP=True negative FN=False negative FP=False positive
Measured: 3 months, 6 months and 12 months
The sensitivity and specificity of the radiomics features in predicting (the first) recurrence of different types and severities of acute pancreatitis at 3, 6 and 12 months
Sensitivity= TP/(TP+FN) Specificity=TN/(TN+FP) Accuracy = (TP+TN)/(TP+FN+TN+FP) TP=True positive TP=True negative FN=False negative FP=False positive
Measured: 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatitis, ChronicStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 694 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Nan, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778929
- Sponsor's protocol ID
- 2022PHB174-001
- Acronym
- RECUR
- Status last verified
- Mar 2023
- First submitted
- 19 Feb 2023
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiomic fEatures of Pancreas From High-Concentration Contrast Enhanced CT Image Predict One-Year RecUrrence Risk of Acute PancReatitis: A Prospective, Multicenter Study
- ClinicalTrials.gov ID
- NCT05778929
- Acronym / sponsor ID
- RECUR / 2022PHB174-001
- Conditions
- Pancreatitis, Chronic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 694 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 22 Mar 2023 (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.
One-year recurrence rate of acute pancreatitis at about 20%. 36% of the patients with recurrent acute pancreatitis will develop into chronic pancreatitis. In addition to negative impact on patient's quality of life, chronic pancreatitis is also associated with the occurrence of pancreatic cancer. The etiology of recurrent acute pancreatitis (RAP) can be divided into mechanical obstructive factors (e.g. cholelithiasis, cholestasis), metabolic abnormality and toxic substance factors (e.g. hyperlipidemia and alcoholism), and other or idiopathic factors. At present, the diagnosis and treatment of RAP remains highly challenging. Early identification and intervention on risk factors of recurrence will be effective in reducing incidence and improving prognosis.
Contrast-enhanced Computed Tomography (CT) can not only provide more imaging information and further assess the severity of acute pancreatitis, but also aid in the differentiation of other diseases associated with acute abdominal pain. In addition, radiomics based on raw radiographic data has become a research hotspot in recent years. The purpose of this study is to establish and validate a deep learning model based on high concentration iopromide-enhanced abdominal CT images which is designed to predict the recurrence of pancreatitis in patients with first episode of pancreatitis within the 1-year follow-up period.
Detailed description
Primary objective(s) To evaluate the sensitivity and specificity of the deep-learning integrated model established with relevant clinical factors and radiomic features based on the high concentration (370 mgI/ml) Iopromide-enhanced pancreatic CT obtained within 14 days after the first onset of symptoms for quantitative prediction of (the first) recurrence of acute pancreatitis in 12 months follow-up period.
Sample Size:
According to previously published data, the average time of occurrence of RAP is 12.5 ± 3.6 months and one-year recurrence rate of acute pancreatitis is about 20%. In addition, the recurrence rate is estimated to be about 17% within the 12-month follow-up window in this study, when taking into account the clinical experience of our hospital.
The calculation parameters for sample size of the training set in the study are as follows:
- Z1-α/2 is1.96 at α=0.05
- L, the width of the acceptable 95% confidential interval of sensitivity or specificity, 0.03-0.1
- The sensitivity is 0.85, the specificity is 0.98, and the disease prevalence is 0.17 Calculated based on sensitivity, N1= 1.962X0.85 X (1-0.85)/0.12 X 0.17= 0.490/0.0017=288 Calculated based on specificity, N2=1.962X0.98 X (1-0.98)/0.12 X (1-0.17) = 0.075/0.008=61 The sample size of the training set is 288 x 1.2 = 346 considering a dropout rate of 20% in the study.
The training set, test set and validation set are estimated in a ratio of 5:2:3. The total sample size for this prospective study is 694. According to the order of patient enrollment, the last 200 patients recruited will form the validation set.
Statistical Analyses:
At baseline and follow-up, descriptive statistics will be used to describe the entire population and subgroups of interest. Summary statistics such as mean, median, standard deviation and range will be used to describe continuous variables. Categorical variables will be presented in a frequency table.
- Primary endpoint analysis For patients with acute pancreatitis undergoing enhanced CT scan, the model that used the combination of radiomics and clinical features is used to predict the recurrence probability of acute pancreatitis within 12 months. The sensitivity and specificity of prediction and corresponding 95% CI are calculated.
- Secondary endpoint analysis Chi-square testing for all potential clinical risk factors included (as described in the Chapter on Variables and Criteria Used in Determining Primary Endpoints). The variables with p< 0.05 are analyzed for multivariate logistic regression and clinical modeling. Also based on the logistic regression model, a combination model of radioomic features and clinical factors is established.
The sensitivity, specificity and corresponding 95% CI for prediction of recurrence within 1, 3, 6 and 12 months are calculated based on the model that used both clinical features and/or radiomics features. Only the first recurrence is calculated.
Brief statistics of the quality of CT images will be provided.
- Baseline demographic characteristics Demographic and baseline characteristics will be summarized descriptively. Sensitivity= TP/(TP+FN) Specificity=TN/(TN+FP) Accuracy = (TP+TN)/(TP+FN+TN+FP) TP=True positive TP=True negative FN=False negative FP=False positive TP+FN+TN+FP=Total number of patients Statistical analyses are performed using R software (R Core Team, Vienna, Austria) version 3.4.3 All tests are two-sided. A P value < 0.05 is considered statistically significant.
All therapies will be coded using the World Health Organization - Drug Dictionary (WHO-DD). Medical history and any disease will be coded using the most current version of ICH Medical Dictionary for Regulatory Activities (MedDRA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients diagnosed as recurrent acute pancreatitis in 12 month | – | Diagnostic Test: Radiomics ModelRecurrent acute pancreatitis: relapse occurs more than three months after the previous episode ended, with the exclusion of re-hospitalization due to local or systemic complications of the initial episode and chronic pancreatitis. |
| patients not diagnosed as recurrent acute pancreatitis in 12 months | – | Diagnostic Test: Radiomics ModelNo relapse occurs more than three months after the previous episode ended, with the exclusion of re-hospitalization due to local or systemic complications of the initial episode and chronic pancreatitis. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects enrolled in this prospective study are adult patients diagnosed as the first onset of acute pancreatitis and recommended for enhanced pancreatic CT scan within 14 days after onset of symptoms and accepted follow-up via telephone or returning to the site at 1, 3, 6 and 12 months.
Key inclusion criteria (5 listed)
- 18 -70 years old
- The subject met the following three criteria and diagnosed with acute pancreatitis according to the Atlanta Classification of Acute Pancreatitis.
- 2.1 Abdominal pain indicative of pancreatitis 2.2 Serum levels of amylase or lipase >3 times the upper limit of normal 2.3 Characteristic findings from abdominal imaging (unenhanced CT\MR\ultrasonography)
- Referred for an enhanced CT examination with Iopromide 370 in 14 days after symptom onset by clinicians
- Sign the informed consent
Key exclusion criteria (12 listed)
- Has history of allergy to iodinated contrast agent
- Confirmed or suspected hyperthyroidism or pheochromocytoma;
- Pregnant or lactating women
- Patients who are participating another clinical study
- Disturbance of consciousness
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 |
|---|---|---|
| Radiomics ModelA total of 694 consecutive eligible patients with first episode of "acute pancreatitis" that recommended for iopromide 370 mgI/ml enhanced pancreatic CT scan within 14 days after onset of symptoms (the sample size ratio of training set: test set: validation set is 5:2:3) will be sequentially enrolled at 10 sites (This study is observational in nature. The routine enhanced pancreatic CT protocol at all selected sites is similar or equivalent to that used in the PI site in the study). Relevant clinical information of the enrolled subjects is collected. Radiomics features are extracted from the selected regions of interest on pancreatic CT images and classified. The subjects are followed up for 12 months and divided into recurrent group and non-recurrent group according to the first recurrence status. | Diagnostic test | patients diagnosed as recurrent acute pancreatitis in 12 month, patients not diagnosed as recurrent acute pancreatitis in 12 months |
Primary outcome
The sensitivity and specificity of the model established with relevant clinical factors and radiomic features
Time frame: 12 months
Image acquisition at each site is performed by an independent radiologist with ≥ 5 years of work experience. Radiomics features will be extracted from 370 mgI/ml Iopromide-enhanced pancreatic CT obtained within 14 days after the first onset of symptoms to quantitative predict the first recurrence of acute pancreatitis in 12 months follow-up period.Sensitivity= TP/(TP+FN) Specificity=TN/(TN+FP) Accuracy = (TP+TN)/(TP+FN+TN+FP) TP=True positive TP=True negative FN=False negative FP=False positive TP+FN+TN+FP=Total number of patients.
5 secondary outcomes
The total number of subjects who developed the first recurrence of acute pancreatitis (subjects with multiple recurrences, calculated and analyzed according to the time of the earliest recurrence) within 3, 6 and 12 months
Time frame: in 12 months follow up period
The sensitivity and specificity of the deep-learning integrated model established with relevant clinical factors and radiomic features to quantitative predict overall recurrence of acute pancreatitis in 3 and 6 months follow-up period;
Time frame: 3 months, 6 months
The image quality of Iopromide-enhanced pancreatic CT images obtained within 14 days after onset of symptoms
Time frame: 14 days
The sensitivity and specificity of the model determined by radiomics features extracted from images with high quality scores (2-3 points)
Time frame: 3 months, 6 months and 12 months
The sensitivity and specificity of the radiomics features in predicting (the first) recurrence of different types and severities of acute pancreatitis at 3, 6 and 12 months
Time frame: 3 months, 6 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Pancreatitis, Chronic
RecruitingPhase 1
Metabolic Impact of Pancreatic Duct Decompression
Chronic Pancreatitis
RecruitingPhase 1
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of CBT-248 in Healthy Adult Participants
Chronic Pancreatitis
Not yet recruitingObservational study
AI-Assisted Differentiation of Autoimmune Pancreatitis and Pancreatic Cancer Using EUS: A Multicenter Ambispective Study
Autoimmune Pancreatitis, Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)
Active, not recruitingPhase 4
A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatitis, Chronic, run by Peking University People's Hospital.
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 5 inclusion and 12 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 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity and specificity of the model established with relevant clinical factors and radiomic features (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2023.