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

NCT06234553 | Active Not Recruiting

• 2 other identifiers: SK-748RIPA-001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pituitary Adenoma

Outcome Measures

Primary Outcomes (1)

• Recurrence rate of pituitary adenoma

  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.

  1 year after treatment

Secondary Outcomes (1)

• Pathological type of pituitary adenomas

  1 week after treatment

Study Arms (1)

training set and validation set

Retrospective study focusing on the diagnosis and treatment outcomes of pituitary adenomas

Procedure: surgery of pituitary adenomas

Interventions

surgery of pituitary adenomas PROCEDURE

evaluate pathological type and treatment effect after treatment

training set and validation set

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All participants willing to receive brain imaging could be included in this study

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing tiantan hospital

Beijing, 100070, China

Location

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Yanghua Fan, Dr.

  Beijing Tiantan Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 31, 2024
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)