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ImmunoPET Targeting Trophoblast Cell-surface Antigen 2 (Trop-2) in Craniopharyngioma Patients

ImmunoPET Targeting Trophoblast Cell-surface Antigen 2 (Trop-2) in Craniopharyngioma Patients

Recruiting
14-80 years
All
Phase N/A

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Overview

This study aims to investigate 68Ga-MY6349, an immune-PET tracer targeting trophoblast cell surface antigen 2 (Trop2), for the noninvasive diagnosis of craniopharyngioma in vivo.

Description

The trophoblast cell surface antigen 2 (Trop2), encoded by the TACSTD2 gene, is a transmembrane glycoprotein that regulates epithelial malignant transformation and proliferation. Trop2 has been reported to be overexpressed in various epithelial tumors, including craniopharyngioma. 68Ga-MY6349, an immune-PET tracer targeting Trop2, has demonstrated high specificity and sensitivity in visualizing other Trop2-high solid tumors. In this research, patients with primary or recurrent craniopharyngioma scheduled for surgery will receive the preoperative 68Ga-MY6349 PET/CT in addition to standard MRI. Tumor uptake is quantified by the maximum standardized uptake value (SUVmax). The diagnostic performance of 68Ga-MY6349 PET is subsequently compared with MRI and the SUVmax is correlated with Trop2 expression levels in postoperative pathological specimens.

Eligibility

Inclusion criteria:

  • must be able to provide a written informed consent
  • radiologically presumed and/or histologically confirmed craniopharyngioma scheduled for resection
  • adequate clinical condition (Karnofsky performance status ≥70)

Exclusion criteria:

  • concomitant major central nervous system disorders
  • severe hepatic or renal dysfunction
  • history of severe allergy or hypersensitivity to intravenous radiographic contrast agents
  • claustrophobia precluding PET/CT or MRI examinations
  • pregnancy or breastfeeding

Study details
    Craniopharyngioma

NCT07177482

Deling Li

15 October 2025

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