Pituitary ACTH Secreting AdenomaNCT04121988
Diagnostic Yield of Deep Learning Based Denoising MRI in Cushing's Disease
An observational study of Pituitary ACTH Secreting Adenoma, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Negative MRI findings may occur in up to 40% of cases of ACTH producing microadenomas. The aim of the study is to evaluate if detection of ACTH producing microadenomas can be increased using deep learning based denoising MRI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pituitary ACTH Secreting Adenoma
- What is being tested?
- MRI
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jan 2020to 28 Feb 2023
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients of tertiary hospital center
Who may be able to join
- Patients suspected of Cushing disease undergoing MRI
- Signed informed consent
Who cannot join
- Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulates, electronic infusion pumps, etc), because such devices may be displaced or malfunction
- Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential
- Poor MRI image quality due to artifacts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Study of Diagnostic Yield in Cushing's Disease Using Deep Learning Based Denoising MRI
Negative MRI findings may occur in up to 40% of cases of ACTH producing microadenomas. The aim of the study is to evaluate if detection of ACTH producing microadenomas can be increased using deep learning based denoising MRI.
Read the detailed description
Detecting ACTH producing microadenoma in MRI is important in establishing the diagnosis of Cushing disease and may enable patients to avoid additional diagnostic tests such as inferior petrosal sinus sampling. However, detecting ACTH producing microadenoma in MRI remains as a diagnostic challenge due its small size with its median diameter of 5-mm. Many attempts have been made in order to improve the sensitivity of detecting ACTH producing microadenoma. It is generally accepted as standard clinical practice to perform dynamic contrast enhanced T1 weighted image to delineate delayed enhancing microadenonoma in comparison to the background enhancement of the normal gland. Despite these attempts, negative MRI findings may occur in up to 40% of cases of ACTH producing microadenomas and there is a need to improve its detection rate. Theoretically, performing thin slice thickness scans should help detecting the lesion but this is unavoidably accompanied with increased level of noise. Deep learning based denoising algorithm can be applied to reduce the noise level and potentially increase the detection rate of ACTH producing microadenomas. The aim of the study is to evaluate if detection of ACTH producing microadenomas can be increased using deep learning based denoising MRI.
- Conditions
- Pituitary ACTH Secreting Adenoma
- Being tested
- MRI
- Medical subject headings
- Pituitary ACTH Hypersecretion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
1 mm slice thickness with deep learning based reconstruction algorithm applied to the following sequences:
- Coronal T2 weighted imaging
- Dynamic contrast enhanced T1 weighted imaging
- Coronal contrast enhanced T1 weighted imaging
| Study group | Role | What they receive |
|---|---|---|
| Denoising MRI group | Patients suspected of Cushing disease undergoing deep learning based denoising MRI Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of ACTH producing microadenoma
Proportion of positive MRI with visible microadenoma as percentage (%)
Measured: 2 months
Secondary outcomes (1)
Proportion of patients undergoing additional diagnostic tests
Proportion of patients undergoing additional diagnostic tests as percentage (%)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start10 Jan 2020
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Why it stopped: Patients recruitment was difficult and the primary author quitted her role.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pituitary ACTH Secreting AdenomaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Sung Kim, Asan Medical Center
- Investigators
- Ho Sung Kim, MD PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121988
- Sponsor's protocol ID
- AsanMCHSKim_04
- Status last verified
- May 2024
- First submitted
- 8 Oct 2019
- Last updated
- 14 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Grober Y, Grober H, Wintermark M, Jane JA, Oldfield EH. Comparison of MRI techniques for detecting microadenomas in Cushing's disease. J Neurosurg. 2018 Apr;128(4):1051-1057. doi: 10.3171/2017.3.JNS163122. Epub 2017 Apr 28.
PubMed 28452619Law M, Wang R, Liu CJ, Shiroishi MS, Carmichael JD, Mack WJ, Weiss M, Wang DJJ, Toga AW, Zada G. Value of pituitary gland MRI at 7 T in Cushing's disease and relationship to inferior petrosal sinus sampling: case report. J Neurosurg. 2018 Mar 23;130(2):347-351. doi: 10.3171/2017.9.JNS171969. Print 2019 Feb 1.
PubMed 29570013
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Diagnostic Yield in Cushing's Disease Using Deep Learning Based Denoising MRI
- ClinicalTrials.gov ID
- NCT04121988
- Acronym / sponsor ID
- AsanMCHSKim_04
- Conditions
- Pituitary ACTH Secreting Adenoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Patients recruitment was difficult and the primary author quitted her role.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 10 Oct 2019 (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.
Negative MRI findings may occur in up to 40% of cases of ACTH producing microadenomas. The aim of the study is to evaluate if detection of ACTH producing microadenomas can be increased using deep learning based denoising MRI.
Detailed description
Detecting ACTH producing microadenoma in MRI is important in establishing the diagnosis of Cushing disease and may enable patients to avoid additional diagnostic tests such as inferior petrosal sinus sampling. However, detecting ACTH producing microadenoma in MRI remains as a diagnostic challenge due its small size with its median diameter of 5-mm. Many attempts have been made in order to improve the sensitivity of detecting ACTH producing microadenoma. It is generally accepted as standard clinical practice to perform dynamic contrast enhanced T1 weighted image to delineate delayed enhancing microadenonoma in comparison to the background enhancement of the normal gland. Despite these attempts, negative MRI findings may occur in up to 40% of cases of ACTH producing microadenomas and there is a need to improve its detection rate. Theoretically, performing thin slice thickness scans should help detecting the lesion but this is unavoidably accompanied with increased level of noise. Deep learning based denoising algorithm can be applied to reduce the noise level and potentially increase the detection rate of ACTH producing microadenomas. The aim of the study is to evaluate if detection of ACTH producing microadenomas can be increased using deep learning based denoising MRI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Denoising MRI group | – | Diagnostic Test: MRIPatients suspected of Cushing disease undergoing deep learning based denoising MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients of tertiary hospital center
Key inclusion criteria (2 listed)
- Patients suspected of Cushing disease undergoing MRI
- Signed informed consent
Key exclusion criteria (3 listed)
- Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulates, electronic infusion pumps, etc), because such devices may be displaced or malfunction
- Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential
- Poor MRI image quality due to artifacts
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 |
|---|---|---|
| MRI1 mm slice thickness with deep learning based reconstruction algorithm applied to the following sequences: * Coronal T2 weighted imaging * Dynamic contrast enhanced T1 weighted imaging * Coronal contrast enhanced T1 weighted imaging | Diagnostic test | Denoising MRI group |
Primary outcome
Detection rate of ACTH producing microadenoma
Time frame: 2 months
Proportion of positive MRI with visible microadenoma as percentage (%)
1 secondary outcome
Proportion of patients undergoing additional diagnostic tests
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Patients recruitment was difficult and the primary author quitted her role.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Background: PubMed 28452619Grober Y, Grober H, Wintermark M, Jane JA, Oldfield EH. Comparison of MRI techniques for detecting microadenomas in Cushing's disease. J Neurosurg. 2018 Apr;128(4):1051-1057. doi: 10.3171/2017.3.JNS163122. Epub 2017 Apr 28.
- Background: PubMed 29570013Law M, Wang R, Liu CJ, Shiroishi MS, Carmichael JD, Mack WJ, Weiss M, Wang DJJ, Toga AW, Zada G. Value of pituitary gland MRI at 7 T in Cushing's disease and relationship to inferior petrosal sinus sampling: case report. J Neurosurg. 2018 Mar 23;130(2):347-351. doi: 10.3171/2017.9.JNS171969. Print 2019 Feb 1.
- Individual participant dataSharing planned: Undecided
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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.
Ho Sung Kim, MD PhD principal investigator
Asan Medical Center
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 ACTH Secreting Adenoma, run by Asan Medical Center at 1 site in South Korea.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 14 May 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 South Korea. 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?
The study was stopped early (reason given: Patients recruitment was difficult and the primary author quitted her role.). 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?
Detection rate of ACTH producing microadenoma (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04121988, which also lists 2 linked publications.
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 14 May 2024.