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Recruiting NCT07046702

68Ga-MY6349 PET/CT in Solid Tumors

— Observational Solid Tumor Trop2 PET/CT

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 68Ga-MY6349.
Who it may be relevant to
Registry conditions: Solid Tumor, Trop2, PET/CT. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

68Ga-MY6349 PET/CT in Solid Tumors and Compared With 18F-FDG PET/CT

Overview

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 test 68Ga-MY6349
    Each subject receives a single intravenous injection of 68Ga-MY6349 and undergoes PET/CT imaging within the specified time.

Primary outcome measures

  • Evaluate the feasibility of PET/CT imaging with 68Ga-MY6349 for the non-invasive assessment of Trop2 expression in various cancer types. [Time frame: 1 week]
Secondary outcome measures (1)
  • Description of 68Ga-MY6349 uptake by measuring standardized uptake value (SUV) in various types of tumors [Time frame: 1 week]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

China · 1 center
  • The First Affiliated Hospital of Xiamen University — Xiamen

Identifiers

NCT: NCT07046702 · XMYY-2024KY252

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗