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Clinical Trials/NCT06234553
NCT06234553
Active, not recruiting
Not Applicable

Radiomics-based Diagnosis, Treatment and Outcome Prediction for Pituitary Adenoma

Beijing Tiantan Hospital1 site in 1 country200 target enrollmentJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pituitary Adenoma
Sponsor
Beijing Tiantan Hospital
Enrollment
200
Locations
1
Primary Endpoint
Recurrence rate of pituitary adenoma
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

The images of patients with Pituitary adenoma were collected and analyzed based on the methods of radiomics.

Detailed Description

Inclusion of pituitary adenoma patients diagnosed clinically or pathologically 1. Clinical data and pre-treatment imaging data of included patients (DICOM format) 2. Determine the subtype diagnosis of pituitary adenoma based on the patient's clinical and pathological data 3. Collect relevant data of patients before and after treatment 4. Using radiomics methods, extract radiomic features of patients and construct a radiomic model for predicting the diagnosis and treatment response of pituitary adenomas

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
December 31, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Beijing Tiantan Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Gender unlimited, 18-80 years old;
  • Clinical diagnosis of Pituitary Adenoma and receive surgical treatment;
  • Received brain imaging;
  • informed consent signed

Exclusion Criteria

  • Pregnant / lactating women
  • Contraindications of imaging examination
  • Lack of effective clinical data
  • MRI data before treatment cannot be obtained
  • Postoperative pathology not revealed pituitary adenoma

Outcomes

Primary Outcomes

Recurrence rate of pituitary adenoma

Time Frame: 1 year after treatment

The pituitary adenoma recurred 1 year after treatment. The recurrence was assessed by 3 aspects: (1)contrast enhanced MRI showed suspicious tumor growth, such as bone destruction; (2)signs and symptoms that had disappeared after treatment reappeared, such as pressing on nearby nerve tissue and some characteristic appearance; (3)endocrine indexes rose again after reaching the remission standard, iculding Prolactin(PRL)\>30 μg/L in Lactotroph adenoma; growth hormone (GH)\>2.5ng/ml in Somatotroph adenoma, serum cortisol\>800nmol/L at 8am in Corticotroph adenoma, while other types do not consider endocrine indicators.

Secondary Outcomes

  • Pathological type of pituitary adenomas(1 week after treatment)

Study Sites (1)

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