Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06277180
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2024-02-18
Brief Title:
68Ga-TCR-FAPI PETCT Guided Precision Surgery for MTC
Sponsor:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Organization:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Study Overview
Official Title:
Evaluating the Clinical Value of 68Ga-TCR-FAPI PETCT to Guide the Surgical Treatment for Medullary Thyroid Carcinoma MTC
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 PETCT 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 PETCT 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 PETCT 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 PETCT 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 PETCT and the principles of surgery remains the same with differentiated thyroid carcinoma ie 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 PETCT in identifying MTC lesions
Patient will be divided into three arms 1 newly diagnosed MTC and all 68Ga-TCR-FAPI PETCT avid lesions are resected 2 recurrentpersistent MTC and all 68Ga-TCR-FAPI PETCT avid lesions are resected 3 distant metastasis or unresectable lesions shown by 68Ga-TCR-FAPI PETCT imaging but still recommended for surgical treatment The three arms will not be compared between each other but will be separately analyzed
This is a phase II clinical trial to evaluate the capability of 68Ga-labeled targeted covalent radiopharmaceutical TCR fibroblast activation protein inhibitor FAPI PETCT 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 PETCT and the principles of surgery remains the same with differentiated thyroid carcinoma ie 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 PETCT in identifying MTC lesions
Patient will be divided into three arms 1 newly diagnosed MTC and all 68Ga-TCR-FAPI PETCT avid lesions are resected 2 recurrentpersistent MTC and all 68Ga-TCR-FAPI PETCT avid lesions are resected 3 distant metastasis or unresectable lesions shown by 68Ga-TCR-FAPI PETCT imaging but still recommended for surgical treatment The three arms will not be compared between each other but will be separately analyzed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None