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Trial Title:
ImmunoPET Targeting Trophoblast Cell-Surface Antigen 2 (Trop-2) in Thyroid Cancer
NCT ID:
NCT06465017
Condition:
Tumor
Solid Tumor
Thyroid Cancer
Positron-Emission Tomography
Conditions: Official terms:
Thyroid Neoplasms
Thyroid Diseases
Fluorodeoxyglucose F18
Conditions: Keywords:
Tumor
Solid
Positron-Emission Tomography
Trop-2
Diagnosis
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
standard-of-care imaging (18F-FDG and 68Ga-FAPI PET/CT), 68Ga-THP-Trop2 VHH PET/CT
Description:
Each subject receives a single intravenous injection of standard-of-care imaging
radiopharmaceuticals (18F-FDG and 68Ga-FAPI) and 68Ga-THP-Trop2 VHH, and undergoes PET/CT
imaging within the specified time.
Arm group label:
68Ga-THP-Trop2 VHH
Summary:
The objective of the study is to construct a noninvasive approach 68Ga-THP-Trop2 VHH
PET/CT to detect the Trop-2 expression of tumor lesions in patients with thyroid cancer
and to identify patients benefiting from Trop-2 targeting antibody-drug conjugate
treatment.
Detailed description:
As a new trophoblast cell-surface antigen 2 (Trop-2) targeting PET radiotracer,
68Ga-THP-Trop2 VHH is promising as an excellent imaging agent applicable to various
cancers. In this research, subjects with thyroid cancer or highly suspected recurrence
detection underwent contemporaneous 68Ga-THP-Trop2 VHH and standard-of-care imaging
(18F-FDG and 68Ga-FAPI PET/CT) either for an initial assessment or for metastases or
highly suspected recurrence detection. Tumor uptake was quantified by the maximum
standard uptake value (SUVmax). The numbers of positive tumor lesions of standard-of-care
imaging and 68Ga-THP-Trop2 VHH PET/CT were recorded by visual interpretation. The
diagnostic accuracy of 68Ga-THP-Trop2 VHH was calculated and compared to standard-of-care
imaging.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Adult patients (aged 18 years or older);
- Patients with newly diagnosed, highly suspected recurrence or previously treated
metastases of thyroid cancer (supporting evidence may include MRI, CT, tumor
markers, and pathology report);
- Patients who had scheduled both standard-of-care imaging (18F-FDG and 68Ga-FAPI
PET/CT) and 68Ga-THP-Trop2 VHH PET/CT 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.
Exclusion Criteria:
- Patients with pregnancy;
- The inability or unwillingness of the research participant, parent or legal
representative to provide written informed consent.
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
The First Affiliated Hospital of Xiamen University
Address:
City:
Xiamen
Zip:
361003
Country:
China
Status:
Recruiting
Contact:
Last name:
Haojun Chen, MD, PhD
Phone:
+8618659285282
Email:
leochen0821@foxmail.com
Contact backup:
Last name:
Hao Fu, MD, PhD
Phone:
+8615959230059
Email:
fuhaonuclear@163.com
Start date:
June 12, 2024
Completion date:
June 30, 2026
Lead sponsor:
Agency:
The First Affiliated Hospital of Xiamen University
Agency class:
Other
Source:
The First Affiliated Hospital of Xiamen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06465017
