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

Deling Li

Status

Enrolling

Conditions

Craniopharyngioma

Treatments

Diagnostic Test: 68Ga-MY6349 PET/CT

Study type

Interventional

Funder types

Other

Identifiers

NCT07177482

BTHospital-N-010

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

14 to 80 years old

Volunteers

No Healthy Volunteers

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