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

Deling Li20 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Craniopharyngioma

Interventions

68Ga-MY6349 PET/CTDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 14 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Standardized uptake value of 68Ga-MY6349 in PET imaging of craniopharyngioma

The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in craniopharyngioma will be measured.

Time frame: Within 1 week after PET imaging.

Secondary Outcomes

Evaluate the feasibility of PET/CT imaging with 68Ga-MY6349 for the non-invasive assessment of Trop2 expression in craniopharyngioma.

Trop2 expression analysis in tumor sample will be correlated to 68Ga-MY6349 tumor uptake, evaluated by measuring standardized uptake value (SUV) on the 68Ga-MY6349 PET/CT.

Time frame: Within 2 week after surgery.

Central Contacts

Deling Li, MD

CONTACT

+86 13810098236 lideling@bjtth.org

Data from ClinicalTrials.gov

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