Application of Radiomics in the Diagnosis and Treatment Prediction of Pituitary Adenoma (RIPA)

February 4, 2024 updated by: Beijing Tiantan Hospital

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100070
        • Beijing Tiantan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
training set and validation set
Retrospective study focusing on the diagnosis and treatment outcomes of pituitary adenomas
Procedure: surgery of pituitary adenomas
evaluate pathological type and treatment effect after treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological type of pituitary adenomas
Time Frame: 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.
1 week after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Investigators

  • Study Director: Yanghua Fan, Dr., Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 18, 2023

First Submitted That Met QC Criteria

January 28, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 4, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SK-748
  • RIPA-001 (Other Identifier: tiantan hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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