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

Not Applicable

Completed

• Conditions: Tumor; Solid Tumor; Thyroid Cancer; Positron-Emission Tomography
• Interventions: Diagnostic Test: standard-of-care imaging (18F-FDG and 68Ga-FAPI PET/CT), 68Ga-THP-Trop2 VHH PET/CT

• Registration Number: NCT06465017
• Lead Sponsor: The First Affiliated Hospital of Xiamen University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2024-06-12
• Study First Submitted: 2024-06-13
• Study First Submitted QC: 2024-06-13
• Study First Posted: 2024-06-18
• Status Verified: 2025-03
• Primary Completion: 2025-03-27
• Study Completion: 2025-03-27
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Adult patients (aged 18 years or older);
• Patients with newly diagnosed, highly suspected recurrence or previously treated metastases of thyroid cancer (supporting evidence may include MRI, CT, tumor markers, and pathology report);
• Patients who had scheduled both standard-of-care imaging (18F-FDG and 68Ga-FAPI PET/CT) and 68Ga-THP-Trop2 VHH PET/CT scans;
• Patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria

• Patients with pregnancy;
• The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-THP-Trop2 VHH	standard-of-care imaging (18F-FDG and 68Ga-FAPI PET/CT), 68Ga-THP-Trop2 VHH PET/CT	Each subject receives a single intravenous injection of 68Ga-THP-Trop2 VHH and undergoes PET/CT imaging within the specified time.

Primary Outcome Measures

Name	Time	Method
Diagnostic efficacy	2 years	The sensitivity, specificity, and accuracy of standard-of-care imaging (18F-FDG and 68Ga-FAPI PET/CT) and 68Ga-THP-Trop2 VHH PET/CT were calculated and compared to evaluate the diagnostic accuracy.

Secondary Outcome Measures

Name	Time	Method
Number of lesions	2 years	The numbers of positive primary and metastatic lesions of standard-of-care imaging (18F-FDG and 68Ga-FAPI PET/CT) and 68Ga-THP-Trop2 VHH PET/CT were recorded by visual interpretation.
SUV	2 years	Standardized uptake value (SUV) of standard-of-care imaging (18F-FDG and 68Ga-FAPI PET/CT) and 68Ga-THP-Trop2 VHH PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis.

Trial Locations

Locations (1)

The First Affiliated Hospital of Xiamen University; 🇨🇳 Xiamen, Fujian, China