Fibroblast Activation Protein Inhibitor, Medullary Thyroid Cancer, Prositron Emission Tomography, Surgery
Conditions
Keywords
Medullary Thyroid Cancer, Prositron Emission Tomography, Fibroblast Activation Protein Inhibitor, Surgery
Brief summary
This is a phase II clinical trial to evaluate the capability of 68Ga-labeled targeted covalent radiopharmaceutical (TCR) fibroblast activation protein inhibitor (FAPI) PET/CT to guide the surgical treatment of medullary thyroid carcinoma (MTC). The surgical extent of MTC is determined based on the lesion range revealed by 68Ga-TCR-FAPI PET/CT, with the main endpoint being 1-month post-surgical calcitonin level.
Detailed description
Surgery remains the only curative option for MTC, yet the current imaging-based method (ultrasound, CT, MRI, 18F-FDG PET/CT) or calcitonin-based method are insufficient to map the extent of disease. In the previous studies, TCR-FAPI can covalently bind to FAP that increase tumor uptake and tumor retention, and better diagnosed MTC than the current radiotracers. This is a phase II clinical trial to evaluate the capability of 68Ga-labeled targeted covalent radiopharmaceutical (TCR) fibroblast activation protein inhibitor (FAPI) PET/CT to guide the surgical treatment of medullary thyroid carcinoma (MTC). The surgical extent of MTC is determined based on the lesion range revealed by 68Ga-TCR-FAPI PET/CT, and the principles of surgery remains the same with differentiated thyroid carcinoma (i.e., lymph node dissection of level II-IV is required if lateral neck lymph node is considered metastasis). The primary endpoint of the study is 1-month post-surgical calcitonin level, and the secondary endpoints include the 2-year event free survival (EFS), the ratio of patient that change surgical plan, and the accuracy, sensitivity, specificity of 68Ga-TCR-FAPI PET/CT in identifying MTC lesions. Patient will be divided into three arms: 1) newly diagnosed MTC and all 68Ga-TCR-FAPI PET/CT avid lesions are resected; 2) recurrent/persistent MTC and all 68Ga-TCR-FAPI PET/CT avid lesions are resected; 3) distant metastasis or unresectable lesions shown by 68Ga-TCR-FAPI PET/CT imaging but still recommended for surgical treatment. The three arms will not be compared between each other but will be separately analyzed.
Interventions
PROCEDURESurgery
Surgery is performed based on the lesion range revealed by 68Ga-TCR-FAPI PET/CT, and all 68Ga-TCR-FAPI-avid lesions are resected.
Sponsors
Peking University
Peking University Cancer Hospital & Institute
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 75 years； * Diagnosed with MTC and have surgical indication based on preliminary evaluation; the tumor may be newly diagnosed or previously treated; * Expected survival of at least 12 weeks; * No major organ dysfunction (heart, lung, liver, kidney and other major organ include), acute or life-threatening status of infection; * Be willing and able to understand the research content and provide written informed consent/assent for the trial.
Exclusion criteria
* Have a history of imaging agent allergies; * Does not meet the PET-CT scan sedation requirements, or has contraindications for PET-CT examination; * Be pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial; * No surgical indication (i.e., no measurable disease, unresectable disease, or significant present of distant metastasis), refusing surgery or 68Ga-TCR-FAPI PET/CT-guided surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-month post-surgery calcitonin level | 1-month post-surgery | 1-month post-surgery calcitonin level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2-year event free survival | 2-year post-surgery | 2-year event free survival |
| Ratio of patient that change surgical plan | immediately after surgery | Ratio of patient that change surgical plan |
| Accuracy, sensitivity, specificity of 68Ga-TCR-FAPI PET/CT in identifying MTC lesions | 1-month post-surgery | Accuracy, sensitivity, specificity of 68Ga-TCR-FAPI PET/CT in identifying MTC lesions |
Countries
China
Contacts
Primary ContactShaoyan Liu, M.D.
Outcome results
None listed