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

NCT ID: NCT07177482

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-04

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Craniopharyngioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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68Ga-MY6349 PET/CT

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

Group Type EXPERIMENTAL

68Ga-MY6349 PET/CT

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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68Ga-MY6349 PET/CT

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

Deling Li

OTHER

Sponsor Role lead

Responsible Party

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Deling Li

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Deling Li, MD

Role: STUDY_CHAIR

Beijing Tiantan Hospital

Locations

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Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Deling Li, MD

Role: CONTACT

+86 13810098236

Facility Contacts

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Deling Li, MD

Role: primary

+86 13810098236

Other Identifiers

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BTHospital-N-010

Identifier Type: -

Identifier Source: org_study_id

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