Evaluation of Lung Metastases Based on Ultrashort Echo Ti... | NCT05763173

Studies
Evaluation of Lung Metastases Based on Ultrashort Echo Time MRI

NCT05763173

Sponsor

RenJi Hospital

Status

Completed

Last Update Posted

Apr 18, 2024Actual

Enrollment

65Actual

Phase

Not provided

Conditions

Hepatoblastoma
Radiology

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Feb 29, 2024Actual

Completion Date

Feb 29, 2024Actual

First Submitted Date

Feb 28, 2023

First Submission Date that Met QC Criteria

Feb 28, 2023

First Posted Date

Mar 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2024

Last Update Posted Date

Apr 18, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

65Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Baseline to 14 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

14 Years

Standard Ages

Child

Study Population

Children diagnosed as hepatoblastoma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Radiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University		Shanghai	Shanghai Municipality	200127	China

ID	Term
D018193	Neoplasms, Complex and Mixed
D009370	Neoplasms by Histologic Type
D009369	Neoplasms