ImmunoPET Targeting Trophoblast Cell-Surface Antigen 2 (Trop-2) in Thyroid Cancer

Last updated: March 27, 2025
Sponsor: The First Affiliated Hospital of Xiamen University
Overall Status: Completed

Phase

N/A

Condition

Thyroid Cancer

Neuroblastoma

Carcinoma

Treatment

standard-of-care imaging (18F-FDG and 68Ga-FAPI PET/CT), 68Ga-THP-Trop2 VHH PET/CT

Clinical Study ID

NCT06465017
XMYY-2021KY024
  • Ages 18-90
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The objective of the study is to construct a noninvasive approach 68Ga-THP-Trop2 VHH PET/CT to detect the Trop-2 expression of tumor lesions in patients with thyroid cancer and to identify patients benefiting from Trop-2 targeting antibody-drug conjugate treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients (aged 18 years or older);

  • Patients with newly diagnosed, highly suspected recurrence or previously treatedmetastases of thyroid cancer (supporting evidence may include MRI, CT, tumormarkers, and pathology report);

  • Patients who had scheduled both standard-of-care imaging (18F-FDG and 68Ga-FAPIPET/CT) and 68Ga-THP-Trop2 VHH PET/CT scans;

  • Patients who were able to provide informed consent (signed by participant, parent orlegal representative) and assent according to the guidelines of the ClinicalResearch Ethics Committee.

Exclusion

Exclusion Criteria:

  • Patients with pregnancy;

  • The inability or unwillingness of the research participant, parent or legalrepresentative to provide written informed consent.

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: standard-of-care imaging (18F-FDG and 68Ga-FAPI PET/CT), 68Ga-THP-Trop2 VHH PET/CT
Phase:
Study Start date:
June 12, 2024
Estimated Completion Date:
March 27, 2025

Study Description

As a new trophoblast cell-surface antigen 2 (Trop-2) targeting PET radiotracer, 68Ga-THP-Trop2 VHH is promising as an excellent imaging agent applicable to various cancers. In this research, subjects with thyroid cancer or highly suspected recurrence detection underwent contemporaneous 68Ga-THP-Trop2 VHH and standard-of-care imaging (18F-FDG and 68Ga-FAPI PET/CT) either for an initial assessment or for metastases or highly suspected recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of positive tumor lesions of standard-of-care imaging and 68Ga-THP-Trop2 VHH PET/CT were recorded by visual interpretation. The diagnostic accuracy of 68Ga-THP-Trop2 VHH was calculated and compared to standard-of-care imaging.

Connect with a study center

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian 361003
    China

    Site Not Available

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