68Ga-MY6349 PET/CT in Solid Tumors

NCT07046702 | Recruiting

• 1 other identifier: XMYY-2024KY252
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor; Trop2; PET/CT

Keywords

Solid tumor; Trop2; PET/CT

Outcome Measures

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.

  1 week

Secondary Outcomes (1)

• Description of 68Ga-MY6349 uptake by measuring standardized uptake value (SUV) in various types of tumors

  1 week

Other Outcomes (1)

• To investigate the superiority of 68Ga-MY6349 PET/CT over 18F-FDG PET/CT in some tumors through comparative analysis.

  2 weeks

Interventions

68Ga-MY6349 DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Audult patients with solid tumor who had scheduled both standard-of-care imaging and 68Ga-MY6349 PET/CT scans.

You may qualify if:

• 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

You may not qualify if:

• patients with pregnancy
• the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361000, China

RECRUITING

Central Study Contacts

Liang Zhao, MD, PhD

CONTACT

86 18818350620; wzhaoliang01@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start: December 10, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)