The Value of 68Ga-FAPI PET/CT in Preoperative Evaluation... | NCT06730529

Studies
The Value of 68Ga-FAPI PET/CT in Preoperative Evaluation of Thyroid Cancer with Lymph Node Metastases

NCT06730529

Sponsor

Ruijin Hospital

Status

Recruiting

Last Update Posted

Dec 12, 2024Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Thyroid Cancer

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

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 29, 2024Actual

Primary Completion Date

Dec 31, 2029Estimated

Completion Date

Dec 31, 2029Estimated

First Submitted Date

Dec 9, 2024

First Submission Date that Met QC Criteria

Dec 9, 2024

First Posted Date

Dec 12, 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

Dec 9, 2024

Last Update Posted Date

Dec 12, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to investigate the value of 68Ga-FAPI in the preoperative evaluation of thyroid cancer of different pathologic types.

Detailed Description

The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo a 68Ga-FAPI PET/CT before surgery. The imaging response measurements will be compared with the histopathological results as gold standard.

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

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Label	Type	Description	Intervention Names
Patients diagnosis of thyroid cancer with lymph node metastases

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical staging of thyroid cancer with lymph node metastasis	The value of 68Ga-FAPI PET/CT in the evaluation of thyroid cancer with lymph node metastases in clinical staging	Within 1 week after enrollment

Secondary Outcomes

Measure	Description	Time Frame
Standardized uptake value(SUV)	SUV of 68Ga-FAPI uptake on PET/CT images for tumor lesions	Within 1 week after enrollment
Disease free survival	Disease free survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pathological and clinical diagnosis of thyroid cancer with lymph node metastases.
Signed and dated informed consent form.
Commitment to comply with research procedures and co-operation in the implementation of the full research process.
Aged 16-80 years old.

Exclusion Criteria:

Patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
Intestinal perforation, complete intestinal obstruction.
Pregnant women and women who may be pregnant, women who are breastfeeding.
Non-compliant person.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Inpatients and outpatients at Ruijin Hospital who meet the inclusion criteria.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jiajia Hu	Contact	13524945287		jiajiahu@shsmu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine	Recruiting	Shanghai	Shanghai Municipality	200001	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013964	Thyroid Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D006258	Head and Neck Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided