Role of FAPI PET/MR Combined With Gadoxetate Disodium in... | NCT06287411

Studies
Role of FAPI PET/MR Combined With Gadoxetate Disodium in Assessing Hepatic Malignancies

NCT06287411

Sponsor

Xiao Chen

Status

Unknown status

Last Update Posted

Mar 5, 2024Actual

Enrollment

36Estimated

Phase

Not provided

Conditions

Hepatic Malignancies

Interventions

FAPI PET/MR combined with gadoxetate disodium

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

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2023Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Feb 23, 2024

First Submission Date that Met QC Criteria

Feb 23, 2024

First Posted Date

Mar 1, 2024Actual

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

Mar 3, 2024

Last Update Posted Date

Mar 5, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiao Chen, Director of Nuclear Medicine Department, Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversitySponsor-Investigator

Lead Sponsor

Xiao ChenOTHER

Collaborators

Not provided

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

Description Module

Brief Summary

This study aimed to prospectively evaluate the utility of fibroblast activation protein inhibitor (FAPI) positron emission tomography (PET)/magnetic resonance (MR) combined with gadoxetate disodium in patients with clinical suspected hepatic malignancies (lesion diameter ≤ 3.0cm), with histopathological findings obtained from biopsy or resected surgical specimens, or follow-up results as reference standards.

Detailed Description

Clinical and biological data, including the course of disease, underlying liver disease (hepatitis or cirrhosis), serum alpha-fetoprotein, carcinoembryonic antigen and carbohydrate antigen 19-9 levels were collected from each patient.
PET image analysis: Each patient underwent both FAPI and fluorodeoxyglucose (FDG) PET/MR, including T1-weighted imaging (T1WI), T2-weighted imaging (T2WI), diffusion-weighted imaging (DWI), apparent diffusion coefficient (ADC) and gadoxetate disodium-enhanced MRI. Record and evaluate the following indicators: the maximum standardized uptake value (SUVmax) of lesions, the target-to-background ratio (TBR) which was calculated by dividing the SUVmax of the lesion by the background SUVmean obtained from nontumor liver tissue.
Pathological analysis: Hematoxylin and eosin staining and immunohistochemical analyses will be performed. Immunohistochemical analysis will be used to investigate the expression of glucose transporter-1 (GLUT-1) and fibroblast activation protein (FAP).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

36Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FAPI PET/MR combined with gadoxetate disodium	Diagnostic Test	Patients with clinical suspected hepatic malignancies will receive the FAPI PET/MR.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic performance	sensitivity, specificity, accuracy, positive and negative predictive values	through study completion, an average of 2 years

Secondary Outcomes

Measure	Description	Time Frame
Quantitative parameters of PET/MR	the maximum standardized uptake value and tumour-to-background ratios	completed within one week after the PET examination

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient ≥ 18 years of age at the time of consent;
Patients with suspected, newly diagnosed, or previously treated liver cancer;
Estimated creatinine clearance > 30ml/min;
Provided written informed consent authorisation before participating in the study.

Exclusion Criteria:

Allergic to the gadoxetate disodium；
MRI contraindications, not limited to cardiac implantable electronic devices and claustrophobia;
Weight > 90Kg;
Pregnancy or lactation;
Active inflammation may affect FAPI imaging.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The subjects the investigators selected are adults who are not restricted by gender.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiao Chen, Ph.D	Contact	+8615922970174		xiaochen229@foxmail.com

Overall Officials

Name	Affiliation	Role
Xiao Chen, Ph.D	Daping Hospital, Army Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Nuclear Medicine, Daping Hospital of Army Medical University	Recruiting	Chongqing	Chongqing Municipality	400010	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33179149	Background	Guo W, Pang Y, Yao L, Zhao L, Fan C, Ke J, Guo P, Hao B, Fu H, Xie C, Lin Q, Wu H, Sun L, Chen H. Imaging fibroblast activation protein in liver cancer: a single-center post hoc retrospective analysis to compare [68Ga]Ga-FAPI-04 PET/CT versus MRI and [18F]-FDG PET/CT. Eur J Nucl Med Mol Imaging. 2021 May;48(5):1604-1617. doi: 10.1007/s00259-020-05095-0. Epub 2020 Nov 11.