Hepatolenticular Degeneration; WilsonNCT06196931
Clinical Value of DWI-ADC Matching in the Short-term Prognosis of Wilson's Disease
An observational study of Hepatolenticular Degeneration; Wilson, run by Hospital Affiliated to the Institute of Neurology, Anhui University of Chinese Medicine at 1 site in China.
Trial summary
In earlier studies, it was found that patients of Wilson disease with new diagnosed who only has neurological symptoms often had DWI hyper-intensity in brain MRI, which was more common in putamen and midbrain, indicating that the disease was in the acute stage. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatolenticular Degeneration; Wilson
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: WD should be considered in patients with unexplained liver disease, neurological symptoms (especially extrapyramidal symptoms), or psychiatric symptoms. Age of onset cannot be used as a basis for diagnosing or ruling out WD. Among these, patients had been previously diagnosed with WD who both had DWI hyper-intensity and ADC hyper-intensity or hypo-intensity at the same time. At the time of admission, the Unified Wilson Disease Rating Scale (UWDRS) and cranial MRI examinations were conducted to assess the state of the disease. All patients received Cu-chelating therapy according to the Chinese guidelines for the diagnosis and treatment of WD (Neurogenetics Group and Neurology Branch of Chinese Medical Association, 2021). During the course of treatment, serum copper, ceruloplasmin, and urine copper at 24 h before treatment and the highest urine copper at 24 h during treatment were tested to determine the efficacy of treatment.
Who may be able to join
- Patients had been previously diagnosed with WD who both had DWI hyper-intensity and ADC hyper-intensity or hypo-intensity at the same time；
- Patients who accept de-copper treatment in hospitalization for 4 weeks or more.
Who cannot join
- Patients who only with liver injury;
- Severe complications;
- Combined with other diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The affiliated hospital of Institute of Neurology in Anhui University of Chinese Medicine
Hefei, Anhui, 230001
About this study
In earlier studies, it was found that patients of Wilson disease with new diagnosed who only has neurological symptoms often had DWI hyper-intensity in brain MRI, which was more common in putamen and midbrain, indicating that the disease was in the acute stage. However, many patients had ADC hyper-intensity or hypo-intensity at the same time, and the two different signals represented different disease processes from an imaging perspective. The former indicating T2 penetration effect, and the latter represents diffusion limitation, which indicating the presence of local inflammation, edema, etc. Whether the signal changes of these two different matching modes have guiding significance for the early de-copper treatment for WD, one is the core point of our study. We hope to exploring the predictive value about DWI-ACD signal matching for symptoms changes in the earlier time of de-copper treatment through this study.
- Conditions
- Hepatolenticular Degeneration; Wilson
- Keywords
- DWI-ADC matching, Wilson disease, clinical value, short-term prognosis
- Medical subject headings
- Hepatolenticular Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
UWDRS scales
It is used to evaluate the changes of patients' nervous system symptoms
Measured: Before and 4 weeks after treatment
24h urine copper
used to evaluate the changes of patients' nervous system symptoms
Measured: Before and 4 weeks after treatment
Secondary outcomes (2)
Semi-quantitative brain MRI score
It is used to evaluate the changes of patients' nervous system symptoms
Measured: Before de-copper treatment
ALT, AST and other liver function test
used to evaluate the changes of patients' nervous system symptoms
Measured: Before and 4 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start1 Jan 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatolenticular Degeneration; WilsonStudies of the same condition, open and under way.
- 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
- Hospital Affiliated to the Institute of Neurology, Anhui University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196931
- Sponsor's protocol ID
- AHnkyy20231020
- Status last verified
- Dec 2023
- First submitted
- 25 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Value of DWI-ADC Matching in the Short-term Prognosis of Wilson's Disease
- ClinicalTrials.gov ID
- NCT06196931
- Acronym / sponsor ID
- AHnkyy20231020
- Conditions
- Hepatolenticular Degeneration; Wilson
- Keywords
- DWI-ADC matching, Wilson disease, clinical value, short-term prognosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospital Affiliated to the Institute of Neurology, Anhui University of Chinese MedicineUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 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.
In earlier studies, it was found that patients of Wilson disease with new diagnosed who only has neurological symptoms often had DWI hyper-intensity in brain MRI, which was more common in putamen and midbrain, indicating that the disease was in the acute stage. However, many patients had ADC hyper-intensity or hypo-intensity at the same time, and the two different signals represented different disease processes from an imaging perspective. The former indicating T2 penetration effect, and the latter represents diffusion limitation, which indicating the presence of local inflammation, edema, etc. Whether the signal changes of these two different matching modes have guiding significance for the early de-copper treatment for WD, one is the core point of our study. We hope to exploring the predictive value about DWI-ACD signal matching for symptoms changes in the earlier time of de-copper treatment through this study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- WD should be considered in patients with unexplained liver disease, neurological symptoms (especially extrapyramidal symptoms), or psychiatric symptoms. Age of onset cannot be used as a basis for diagnosing or ruling out WD. Among these, patients had been previously diagnosed with WD who both had DWI hyper-intensity and ADC hyper-intensity or hypo-intensity at the same time. At the time of admission, the Unified Wilson Disease Rating Scale (UWDRS) and cranial MRI examinations were conducted to assess the state of the disease. All patients received Cu-chelating therapy according to the Chinese guidelines for the diagnosis and treatment of WD (Neurogenetics Group and Neurology Branch of Chinese Medical Association, 2021). During the course of treatment, serum copper, ceruloplasmin, and urine copper at 24 h before treatment and the highest urine copper at 24 h during treatment were tested to determine the efficacy of treatment.
Key inclusion criteria (2 listed)
- Patients had been previously diagnosed with WD who both had DWI hyper-intensity and ADC hyper-intensity or hypo-intensity at the same time；
- Patients who accept de-copper treatment in hospitalization for 4 weeks or more.
Key exclusion criteria (3 listed)
- Combined with other diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
UWDRS scales
Time frame: Before and 4 weeks after treatment
It is used to evaluate the changes of patients' nervous system symptoms
24h urine copper
Time frame: Before and 4 weeks after treatment
used to evaluate the changes of patients' nervous system symptoms
2 secondary outcomes
Semi-quantitative brain MRI score
Time frame: Before de-copper treatment
ALT, AST and other liver function test
Time frame: Before and 4 weeks after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hepatolenticular Degeneration; Wilson, run by Hospital Affiliated to the Institute of Neurology, Anhui University of Chinese Medicine 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 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: opening soon, as of the sponsor's last update on 9 Jan 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?
This study is still under way. Results are not available in the source record yet.
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?
UWDRS scales (time frame: Before and 4 weeks after treatment). The study lists 2 primary outcomes in all. 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 9 Jan 2024.