Pituitary AdenomaRIPANCT06234553
Application of Radiomics in the Diagnosis and Treatment Prediction of Pituitary Adenoma
An observational study of Pituitary Adenoma, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The images of patients with Pituitary adenoma were collected and analyzed based on the methods of radiomics. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pituitary Adenoma
- What is being tested?
- surgery of pituitary adenomas
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All participants willing to receive brain imaging could be included in this study
Who may be able to join
- Gender unlimited, 18-80 years old;
- Clinical diagnosis of Pituitary Adenoma and receive surgical treatment;
- Received brain imaging;
- informed consent signed
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Inclusion of pituitary adenoma patients diagnosed clinically or pathologically
- Clinical data and pre-treatment imaging data of included patients (DICOM format)
- Determine the subtype diagnosis of pituitary adenoma based on the patient's clinical and pathological data
- Collect relevant data of patients before and after treatment
- Using radiomics methods, extract radiomic features of patients and construct a radiomic model for predicting the diagnosis and treatment response of pituitary adenomas
- Conditions
- Pituitary Adenoma
- Being tested
- surgery of pituitary adenomas
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery of pituitary adenomasProcedure or surgery
evaluate pathological type and treatment effect after treatment
| Study group | Role | What they receive |
|---|---|---|
| training set and validation set | Retrospective study focusing on the diagnosis and treatment outcomes of pituitary adenomas Receives: Procedure: surgery of pituitary adenomas |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year after treatment
Secondary outcomes (1)
Pathological type of pituitary adenomas
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.
Measured: 1 week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Jan 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary AdenomaStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yanghua Fan, Dr., Study director, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234553
- Sponsor's protocol ID
- SK-748
- Other IDs
- RIPA-001
- Acronym
- RIPA
- Status last verified
- Feb 2024
- First submitted
- 18 Dec 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiomics-based Diagnosis, Treatment and Outcome Prediction for Pituitary Adenoma
- ClinicalTrials.gov ID
- NCT06234553
- Acronym / sponsor ID
- RIPA / SK-748
- Conditions
- Pituitary Adenoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Clinical data and pre-treatment imaging data of included patients (DICOM format)
- Determine the subtype diagnosis of pituitary adenoma based on the patient's clinical and pathological data
- Collect relevant data of patients before and after treatment
- Using radiomics methods, extract radiomic features of patients and construct a radiomic model for predicting the diagnosis and treatment response of pituitary adenomas
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| training set and validation set | – | Procedure: surgery of pituitary adenomasRetrospective study focusing on the diagnosis and treatment outcomes of pituitary adenomas |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants willing to receive brain imaging could be included in this study
Key inclusion criteria (4 listed)
- Gender unlimited, 18-80 years old;
- Clinical diagnosis of Pituitary Adenoma and receive surgical treatment;
- Received brain imaging;
- informed consent signed
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgery of pituitary adenomasevaluate pathological type and treatment effect after treatment | Procedure or surgery | training set and validation set |
Primary outcome
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 secondary outcome
Pathological type of pituitary adenomas
Time frame: 1 week after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanghua Fan, Dr. study director
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pituitary Adenoma, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate of pituitary adenoma (time frame: 1 year after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.