PET/CT, Solid Tumor, Trop2
Conditions
Keywords
Solid tumor, Trop2, PET/CT
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TEST68Ga-MY6349
Each subject receives a single intravenous injection of 68Ga-MY6349 and undergoes PET/CT imaging within the specified time.
Sponsors
The First Affiliated Hospital of Xiamen University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients (aged 18 years or older) * patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report) * patients who had scheduled both standard-of-care imaging and 68Ga-MY6349 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the feasibility of PET/CT imaging with 68Ga-MY6349 for the non-invasive assessment of Trop2 expression in various cancer types. | 1 week | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Description of 68Ga-MY6349 uptake by measuring standardized uptake value (SUV) in various types of tumors | 1 week | Standardized uptake value (SUV) of 68Ga-MY6349 PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis. |
Other
| Measure | Time frame | Description |
|---|---|---|
| To investigate the superiority of 68Ga-MY6349 PET/CT over 18F-FDG PET/CT in some tumors through comparative analysis. | 2 weeks | 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. |
Countries
China
Contacts
Primary ContactLiang Zhao, MD, PhD
Outcome results
None listed