NCT06730529

Brief Summary

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

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
43mo left

Started Nov 2024

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 Progress30%
Nov 2024Dec 2029

Study Start

First participant enrolled

November 29, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2024

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

5.1 years

First QC Date

December 9, 2024

Last Update Submit

December 9, 2024

Conditions

Thyroid Cancer

Keywords

Thyroid Cancer68Ga-FAPIPET/CT

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • Standardized uptake value(SUV)

    Within 1 week after enrollment

  • Disease free survival

    3 years

Study Arms (1)

Patients diagnosis of thyroid cancer with lymph node metastases

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (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:

  • 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.

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

December 9, 2024

First Posted

December 12, 2024

Study Start

November 29, 2024

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

December 12, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)