68Ga-MY6349 PET/CT in Solid Tumors

Xiamen University

Status: Enrolling

Conditions: Solid Tumor; PET/CT; Trop2

Treatments: Diagnostic Test: 68Ga-MY6349

Study type: Observational

Funder types: Other

Identifiers

NCT07046702

XMYY-2024KY252

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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