HepatoblastomaNCT05763173
Evaluation of Lung Metastases Based on Ultrashort Echo Time MRI
An observational study of Hepatoblastoma and Radiology, run by RenJi Hospital at 1 site in China.
Trial summary
Analyze the diagnostic efficiency (including performance, diameter, and location of nodules) of UTE-MRI in lung metastases of hepatoblastoma with chest CT as gold standard Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Hepatoblastoma, Radiology
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 29 Feb 2024
- How long will I take part?
- 10 Months
- 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 Up to 14 years
- All sexes
- Child
Study population: Children diagnosed as hepatoblastoma
Who may be able to join
- Children diagnosed as hepatoblastoma (including treated with neoadjuvant chemotherapy but not surgery)
- Recent chest CT scan (within 14 days)
- No MRI contraindications
- The guardian of the children are willing to undergo the examination after full communication and informed consent
Who cannot join
- MRI contraindications (including but not limited to: contrast medium allergy; Claustrophobia;Metal implants;chronic kidney disease≥stage 3 (glomerular filtration rate < 60 mL min-1 (1.73 m2)-1))
- Patients with hepatoblastoma aged 14 years and above
- Children after surgery for hepatoblastoma
- Application of any contrast medium within 24 h before the MRI and/or CT examinations
- There is a concomitant medical condition (e.g. poorly controlled hypertension, severe diabetes, neurological or psychiatric illness, etc.) or any other condition that would seriously endangers the subject's safety, may confuse the study results, or may interfere with the subject's completion of the study according to the investigator's judgment.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Radiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, 200127
About this study
Official title: The Diagnostic Value of Lung Ultrashort Echo Time MRI for Potential Lung Metastases in Children With Hepatoblastoma
Analyze the diagnostic efficiency (including performance, diameter, and location of nodules) of UTE-MRI in lung metastases of hepatoblastoma with chest CT as gold standard
- Conditions
- Hepatoblastoma, Radiology
- Medical subject headings
- Hepatoblastoma
What is being measured
The primary outcome is the main question the study is designed to answer.
UTE-MRI assessment of lung metastases with chest CT as gold standard
Analyze the diagnostic efficiency (including performance, diameter, and location of nodules) of UTE-MRI in lung metastases of hepatoblastoma.
Measured: Baseline to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start1 Jan 2023
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatoblastomaStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763173
- Sponsor's protocol ID
- LY2022-064-B
- Status last verified
- Apr 2024
- First submitted
- 28 Feb 2023
- Last updated
- 18 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Value of Lung Ultrashort Echo Time MRI for Potential Lung Metastases in Children With Hepatoblastoma
- ClinicalTrials.gov ID
- NCT05763173
- Acronym / sponsor ID
- LY2022-064-B
- Conditions
- Hepatoblastoma, Radiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 10 Mar 2023 (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.
Analyze the diagnostic efficiency (including performance, diameter, and location of nodules) of UTE-MRI in lung metastases of hepatoblastoma with chest CT as gold standard
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Months
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Age groups
- Child
- Study population
- Children diagnosed as hepatoblastoma
Key inclusion criteria (4 listed)
- Children diagnosed as hepatoblastoma (including treated with neoadjuvant chemotherapy but not surgery)
- Recent chest CT scan (within 14 days)
- No MRI contraindications
- The guardian of the children are willing to undergo the examination after full communication and informed consent
Key exclusion criteria (5 listed)
- MRI contraindications (including but not limited to: contrast medium allergy; Claustrophobia;Metal implants;chronic kidney disease≥stage 3 (glomerular filtration rate < 60 mL min-1 (1.73 m2)-1))
- Patients with hepatoblastoma aged 14 years and above
- Children after surgery for hepatoblastoma
- Application of any contrast medium within 24 h before the MRI and/or CT examinations
- There is a concomitant medical condition (e.g. poorly controlled hypertension, severe diabetes, neurological or psychiatric illness, etc.) or any other condition that would seriously endangers the subject's safety, may confuse the study results, or may interfere with the subject's completion of the study according to the investigator's judgment.
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
UTE-MRI assessment of lung metastases with chest CT as gold standard
Time frame: Baseline to 14 days
Analyze the diagnostic efficiency (including performance, diameter, and location of nodules) of UTE-MRI in lung metastases of hepatoblastoma.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 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. This study is not recruiting at the moment.
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 Hepatoblastoma and Radiology, run by RenJi 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: finished, as of the sponsor's last update on 18 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
UTE-MRI assessment of lung metastases with chest CT as gold standard (time frame: Baseline to 14 days). 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 18 Apr 2024.