NCT06800768

Brief Summary

This study aims to investigate the value of 68Ga-FAPI PET/CT in detecting recurrent and metastatic lesions in patients with thyroid cancer after surgery.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
44mo left

Started Feb 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress27%
Feb 2025Jan 2030

First Submitted

Initial submission to the registry

January 24, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 30, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2030

Last Updated

January 30, 2025

Status Verified

January 1, 2025

Enrollment Period

5 years

First QC Date

January 24, 2025

Last Update Submit

January 24, 2025

Conditions

Thyroid Cancer

Keywords

Thyroid Cancer68Ga-FAPIPET/CT

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of recurrent or metastatic thyroid cancer

    The value of 68Ga-FAPI PET/CT in detecting recurrent and metastatic lesions in patients with thyroid cancer after surgery

    Within 1 week after enrollment

Secondary Outcomes (2)

  • Standardized uptake value(SUV)

    Within 1 week after enrollment

  • Disease free survival

    3 years

Study Arms (1)

Patients with suspected recurrence or metastasis of thyroid cancer after surgery

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients with thyroid cancer who have undergone surgery and are suspected of recurrence or metastasis during clinical evaluation.
  • Signed and dated informed consent form.
  • Commitment to comply with research procedures and co-operation in the implementation of the full research process.
  • Aged 18-80 years old.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine

Shanghai, Shanghai Municipality, 200001, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Central Study Contacts

Jiajia Hu

CONTACT

13524945287jiajiahu@shsmu.edu.cn

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy director

Study Record Dates

First Submitted

January 24, 2025

First Posted

January 30, 2025

Study Start

February 1, 2025

Primary Completion (Estimated)

January 31, 2030

Study Completion (Estimated)

January 31, 2030

Last Updated

January 30, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)