Application of Radiomics in the Diagnosis and Treatment Prediction of Pituitary Adenoma

Active, not recruiting

• Conditions: Pituitary Adenoma
• Interventions: Procedure: surgery of pituitary adenomas

• Registration Number: NCT06234553
• Lead Sponsor: Beijing Tiantan Hospital

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

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2023-12-18
• Primary Completion: 2023-12-31
• Study First Submitted QC: 2024-01-28
• Study First Posted: 2024-01-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-04
• Last Update Posted: 2024-02-06
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

1. Pregnant / lactating women
2. Contraindications of imaging examination
3. Lack of effective clinical data
4. MRI data before treatment cannot be obtained
5. Postoperative pathology not revealed pituitary adenoma

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
training set and validation set	surgery of pituitary adenomas	Retrospective study focusing on the diagnosis and treatment outcomes of pituitary adenomas

Primary Outcome Measures

Name	Time	Method
Recurrence rate of pituitary adenoma	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 Outcome Measures

Name	Time	Method
Pathological type of pituitary adenomas	1 week after treatment	The pathological examination was used to evaluated the type of pituitary adenoma. The pathological type was assessed by 2017 WHO standard, divided into Somatotroph adenoma, Lactotroph adenoma, Thyrotroph adenoma, Corticotroph adenoma, Gonadotroph adenoma, Null-cell adenoma and Plurihormonal and double adenomas.

Trial Locations

Locations (1)

Beijing tiantan hospital; 🇨🇳 Beijing, China