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

December 9, 2024 updated by: Hu Jiajia, Ruijin Hospital
This study aims to investigate the value of 68Ga-FAPI in the preoperative evaluation of thyroid cancer of different pathologic types.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200001
        • Recruiting
        • Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. Intestinal perforation, complete intestinal obstruction.
  3. Pregnant women and women who may be pregnant, women who are breastfeeding.
  4. Non-compliant person.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients diagnosis of thyroid cancer with lymph node metastases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical staging of thyroid cancer with lymph node metastasis
Time Frame: Within 1 week after enrollment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standardized uptake value(SUV)
Time Frame: Within 1 week after enrollment
SUV of 68Ga-FAPI uptake on PET/CT images for tumor lesions
Within 1 week after enrollment
Disease free survival
Time Frame: 3 years
Disease free survival
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2024

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

December 9, 2024

First Submitted That Met QC Criteria

December 9, 2024

First Posted (Estimated)

December 12, 2024

Study Record Updates

Last Update Posted (Estimated)

December 12, 2024

Last Update Submitted That Met QC Criteria

December 9, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RuijinH 2024-498

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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