Clinical trial · Interventional
ImmunoPET Targeting Trophoblast Cell-Surface Antigen 2 (Trop-2) in Thyroid Cancer
ImmunoPET Targeting Trophoblast Cell-Surface Antigen 2 (Trop-2) in Thyroid Cancer and Compared With 18F-FDG
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was completed as planned after achieving the target enrollment and completing all protocol-specified procedures and follow-up.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Positron-Emission Tomography | — | UNRESOLVED | — |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| standard-of-care imaging (18F-FDG PET/CT), 68Ga-MY6349 PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-MY6349
- description
- Each subject receives a single intravenous injection of 68Ga-MY6349 and undergoes PET/CT imaging within the specified time.
- interventionNames
- Diagnostic Test: standard-of-care imaging (18F-FDG PET/CT), 68Ga-MY6349 PET/CT
Primary outcomes (1)
- measure
- Diagnostic performance (patient-based)
- timeFrame
- 2 years
- description
- The patient-based sensitivity of 68Ga-MY6349 and standard-of-care imaging (18F-FDG PET/CT) were calculated and compared.
Secondary outcomes (5)
- measure
- Diagnostic performance (patient-based)
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available