68Ga-MY6349 PET/CT in Solid Tumors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Xiamen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
patients with pregnancy
the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent
Trial population
Audult patients with solid tumor who had scheduled both standard-of-care imaging and 68Ga-MY6349 PET/CT scans.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
68Ga-MY6349
Diagnostic testEach subject receives a single intravenous injection of 68Ga-MY6349 and undergoes PET/CT imaging within the specified time.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
1 weekSecondary outcomes
1
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.
Time frame
1 weekOther outcomes
1
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.
Time frame
2 weeksSponsors and contacts
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Source ClinicalTrials.gov