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The objective of the study is to construct a noninvasive approach 68Ga-MY6349 PET/CT to detect the Trop-2 expression of tumor lesions in patients with solid tumors and to identify patients benefiting from Trop-2 PET/CT.
As a new trophoblast cell-surface antigen 2 (Trop-2) targeting PET radiotracer, 68Ga-MY6349 is promising as an excellent imaging agent applicable to various cancers. In this research, subjects with various types of tumors underwent contemporaneous 68Ga-MY6349 and standard-of-care imaging (18F-FDG) either for an initial assessment or for 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-MY6349 PET/CT were recorded by visual interpretation. The diagnostic accuracy of 68Ga-MY6349 was calculated and compared to standard-of-care imaging.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-MY6349 | Diagnostic Test | Each subject receives a single intravenous injection of 68Ga-MY6349 and undergoes PET/CT imaging within the specified time. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the feasibility of PET/CT imaging with 68Ga-MY6349 for the non-invasive assessment of Trop2 expression in various cancer types. | Tumor Trop2 expression analysis in a fresh biopsy sample will be correlated to 68Ga-MY6349 tumor uptake, evaluated by measuring standardized uptake value (SUV) on the 68Ga-MY6349 PET/CT. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Description of 68Ga-MY6349 uptake by measuring standardized uptake value (SUV) in various types of tumors | Standardized uptake value (SUV) of 68Ga-MY6349 PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the superiority of 68Ga-MY6349 PET/CT over 18F-FDG PET/CT in some tumors through comparative analysis. | The numbers of positive primary and metastatic lesions of standard-of-care imaging (18F-FDG PET/CT) and 68Ga-MY6349 PET/CT were recorded by visual interpretation. | 2 weeks |
Inclusion Criteria:
Exclusion Criteria:
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Audult patients with solid tumor who had scheduled both standard-of-care imaging and 68Ga-MY6349 PET/CT scans.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liang Zhao, MD, PhD | Contact | 86 18818350620 | wzhaoliang01@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xiamen University | Recruiting | Xiamen | Fujian | 361000 | China |
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