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

Xiamen University

Status: Completed

Conditions: Solid Tumor; Thyroid Cancer; Tumor; Positron-Emission Tomography

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06465017

XMYY-2024KY195

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

68Ga-THP-Trop2 VHH

Experimental group

Description:

Each subject receives a single intravenous injection of 68Ga-THP-Trop2 VHH and undergoes PET/CT imaging within the specified time.

Treatment:

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