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Completed

NCT Number: NCT06188468

ImmunoPET Targeting Trophoblast Cell-surface Antigen 2 (Trop-2) in Solid Tumors

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 targeting antibody-drug conjugate treatment.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

About this study

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, 68Ga-PSMA, or 68Ga-DOTATATE PET/CT) 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 (18F-FDG, 68Ga-PSMA, or 68Ga-DOTATATE PET/CT) 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.

Treatment and study plan

standard-of-care imaging (18F-FDG, 68Ga-PSMA, or 68Ga-DOTATATE PET/CT), 68Ga-MY6349 PET/CT

Diagnostic Test

Each subject receives a single intravenous injection of standard-of-care imaging radiopharmaceuticals (18F-FDG, 68Ga-PSMA, or 68Ga-DOTATATE) and 68Ga-MY6349, and undergoes PET/CT imaging within the specified time.

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.

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 1 week

    Standardized uptake value (SUV) of 68Ga-MY6349 PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Xiamen University

Other

Registry information

Official study title

ImmunoPET Targeting Trophoblast Cell-surface Antigen 2 (Trop-2) in Solid Tumors and Compared with 18F-FDG

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 3, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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