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Pre-operative Surgical Difficulty Stratification Using Predicted Tumor Perfusion and Consistency
Study Purpose
Pituitary adenomas (PAs) are among the most prevalent lesions of the sella turcica, accounting for 10%-25% of all intracranial neoplasms. Pituitary macroadenomas (PMAs) are defined with a maximum diameter of over 1 cm. Tumor characteristics are key factors influencing surgical effectiveness and complications of PMAs, with tumor perfusion and consistency identified as major predictive factors in literature. Conventional sequences provide limited information for predicting the perfusion and consistency of pituitary adenomas. Advanced sequences offer additional insights. However, the efficacy of combining radiomic features from multiparametric sequences, incorporating both conventional and advanced sequences, has not yet been proved. We aim to develop machine learning models that combines radiomic features developed from both conventional and advanced sequences to predict the perfusion and consistency of PMAs. Furthermore, we aim to demonstrate the clinically applicability of these models by constructing a MR-PIT stratification (Multiparametric Radiomic derived and tumor Perfusion and consIsTency based surgical difficulty stratification), which correlated with the surgical strategy and outcomes.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational |
| Eligible Ages | N/A and Over |
| Gender | All |
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT06664190 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Huashan Hospital |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
| Principal Investigator Affiliation | N/A |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
| Overall Status | Active, not recruiting |
| Countries | China |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Pituitary Adenoma |
Contact a Trial Team
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