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Trial Title:
68Ga-TCR-FAPI PET/CT Guided Precision Surgery for MTC
NCT ID:
NCT06277180
Condition:
Medullary Thyroid Cancer
Prositron Emission Tomography
Fibroblast Activation Protein Inhibitor
Surgery
Conditions: Official terms:
Thyroid Neoplasms
Thyroid Diseases
Conditions: Keywords:
Medullary Thyroid Cancer
Prositron Emission Tomography
Fibroblast Activation Protein Inhibitor
Surgery
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Surgery
Description:
Surgery is performed based on the lesion range revealed by 68Ga-TCR-FAPI PET/CT, and all
68Ga-TCR-FAPI-avid lesions are resected.
Arm group label:
Newly diagnosed MTC that resect all 68Ga-TCR-FAPI-avid lesions
Arm group label:
Recurrent/persistent MTC that resect all 68Ga-TCR-FAPI-avid lesions
Intervention type:
Procedure
Intervention name:
Surgery
Description:
68Ga-TCR-FAPI PET/CT identified distant metastasis or unresectable lesions, but the
patient is still recommended to undergo surgery for debulking or reduce symptoms.
Arm group label:
Not all 68Ga-TCR-FAPI-avid lesions can be resected
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Shaoyan Liu, M.D.
Phone:
0086-010-87787190
Email:
shaoyanliu.bj@263.net
Start date:
October 1, 2023
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Peking University
Agency class:
Other
Collaborator:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06277180
