Positron-Emission Tomography, Solid Tumor, Thyroid Cancer, Tumor
Conditions
Keywords
Tumor, Solid, Positron-Emission Tomography, Trop-2, Diagnosis
Brief summary
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. The primary objective of this study was to evaluate the patient-based sensitivity of 68Ga-MY6349 PET/CT in detecting recurrent and metastatic thyroid cancer. The secondary objectives included its overall specificity, lesion-based diagnostic performance, comparative tumor uptake relative to 18F-FDG PET/CT, safety profile, and the impact on clinical management.
Detailed description
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 PET/CT). The primary objective of this study was to evaluate the patient-based sensitivity of 68Ga-MY6349 PET/CT in detecting recurrent and metastatic thyroid cancer. The secondary objectives included its overall specificity, lesion-based diagnostic performance, comparative tumor uptake relative to 18F-FDG PET/CT, safety profile, and the impact on clinical management.
Interventions
DIAGNOSTIC_TESTstandard-of-care imaging (18F-FDG PET/CT), 68Ga-MY6349 PET/CT
Each subject receives a single intravenous injection of standard-of-care imaging radiopharmaceuticals (18F-FDG) 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
Sponsors
The First Affiliated Hospital of Xiamen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance (patient-based) | 2 years | The patient-based sensitivity of 68Ga-MY6349 and standard-of-care imaging (18F-FDG PET/CT) were calculated and compared. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance (patient-based) | 2 years | Patient-based specificity of 68Ga-MY6349 PET/CT and standard-of-care imaging (18F-FDG PET/CT) were calculated and compared. |
| Diagnostic performance | 2 years | Lesion-based diagnostic accuracy (sensitivity, specificity, and accuracy) of 68Ga-MY6349 and standard-of-care imaging (18F-FDG PET/CT) were calculated and compared. |
| SUVmax and TBR | 2 years | Tumor uptake comparison between 68Ga-MY6349 PET/CT and standard-of-care imaging (18F-FDG PET/CT) at the individual lesion level were calculated and compared. |
| 68Ga-MY6349 safety | 24 h | 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. |
| The impact on clinical management | 2-4 weeks | Proportion of patients with change in management plan based on 68Ga-MY6349 PET/CT versus conventional imaging or 18F-FDG PET/CT, which is defiend as the proportion of patients whose clinical management strategy was modified based on 68Ga-MY6349 PET/CT findings, compared to the initial plan derived from conventional imaging or 18F-FDG PET/CT. |
Countries
China
Outcome results
None listed