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

The First Affiliated Hospital of Xiamen University149 enrolled

Overview

In this study, we comprehensively evaluated the clinical utility of Trop2 PET/CT (68Ga-MY6349 PET/CT) imaging for detecting recurrent and metastatic thyroid cancer, and the results were compared with those of 18F-FDG PET/CT and 68Ga-FAPI. The primary objective of this study was to evaluate the patient-based sensitivity and specificity of 68Ga-MY6349 PET/CT in detecting recurrent and metastatic thyroid cancer. The secondary objectives included its overall accuracy, lesion-based diagnostic performance, comparative tumor uptake relative to 18F-FDG PET/CT and 68Ga-FAPI, and safety profile.

Trophoblast cell-surface antigen 2 (Trop2), a transmembrane glycoprotein, is highly expressed in most epithelial cancers but has low expression in most normal tissues. Notably, Trop2 expression is significantly elevated in thyroid cancer, representing an important molecular hallmark of thyroid cancer. Previously, we developed a Trop2-specific radiotracer for PET/CT imaging, 68Ga-MY6349, with the potential for clinical translation across various cancer types. In particular, 68Ga-MY6349 PET/CT demonstrated the highest tumor uptake in PTC across 15 cancer types, enabling visualization of more metastatic lesions than conventional 18F-FDG PET/CT. In this study, we comprehensively evaluated the clinical utility of Trop2 PET/CT imaging for detecting recurrent and metastatic thyroid cancer, and the results were compared with standard-of-care imaging (18F-FDG and 68Ga-FAPI PET/CT). The primary objective of this study was to evaluate the patient-based sensitivity and specificity of 68Ga-MY6349 PET/CT in detecting recurrent and metastatic thyroid cancer. The secondary objectives included its overall accuracy, lesion-based diagnostic performance, comparative tumor uptake relative to 18F-FDG and 68Ga-FAPI PET/CT, and safety profile.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Interventions

standard-of-care imaging (18F-FDG and 68Ga-FAPI PET/CT), 68Ga-MY6349 PET/CTDIAGNOSTIC_TEST

Each subject receives a single intravenous injection of standard-of-care imaging radiopharmaceuticals (18F-FDG and 68Ga-FAPI) and 68Ga-MY6349, and undergoes PET/CT imaging within the specified time. For participants who were not radioiodine-refractory or who did not have MTC or ATC, DxWBS was conducted. Each participant received an intramuscular injection of rhTSH on two consecutive days, followed by the oral administration of 131I. DxWBS was performed 2 days after 131I administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients (aged 18 years or older); * Patients with a history of previously treated thyroid cancer, including DTC and HGFCTC following thyroidectomy with or without 131I therapy, MTC after thyroidectomy, or ATC; either (1) evidence of structural or suspicious lesions on standard of care imaging or (2) biochemical evidence of disease in the absence of structural findings, defined as elevated thyrotropin suppressed thyroglobulin (Tgon ≥1 ng/mL after 131I ablation or ≥5 ng/mL without ablation) with negative anti thyroglobulin antibodies (\<20 IU/mL) for DTC and HGFCTC or elevated calcitonin (\>10 pg/mL) for MTC; * Patients who had scheduled both standard-of-care imaging (18F-FDG and 68Ga-FAPI PET/CT) and 68Ga-MY6349 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. * No other anticancer therapy within four weeks prior to PET imaging. Exclusion Criteria: * Patients with pregnancy or lactating; * Patients had a second primary tumor; * The inability or unwillingness of the research participant, parent, or legal representative to provide written informed consent.

Outcomes

Primary Outcomes

Diagnostic performance (patient-based)

The patient-based sensitivity and specificity of 68Ga-MY6349 and standard-of-care imaging (18F-FDG and 68Ga-FAPI PET/CT) were calculated and compared.

Time frame: 2 years

Secondary Outcomes

Diagnostic accuracy

Patient-based overall accuracy of 68Ga-MY6349 PET/CT and standard-of-care imaging (18F-FDG and 68Ga-FAPI PET/CT) were calculated and compared.

Time frame: 2 years

Diagnostic performance

Lesion-based diagnostic accuracy (sensitivity, specificity, and accuracy) of 68Ga-MY6349 and standard-of-care imaging (18F-FDG and 68Ga-FAPI PET/CT) were calculated and compared.

Time frame: 2 years

SUVmax and TBR

Tumor uptake comparison between 68Ga-MY6349 PET/CT and standard-of-care imaging (18F-FDG and 68Ga-FAPI PET/CT) at the individual lesion level were calculated and compared.

Time frame: 2 years

68Ga-MY6349 safety

Patients were monitored for adverse events (AEs) during and up to 24 h after radiotracer administration. Vital signs, including body temperature, heart rate, and blood pressure, were recorded pre- and post-⁶⁸Ga-MY6349 injection.

Time frame: 24 h

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes