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

NCT07177482 | Recruiting

• 1 other identifier: BTHospital-N-010
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Craniopharyngioma

Keywords

Positron-Emission Tomography; Diagnosis

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 1 week after PET imaging.

Secondary Outcomes (1)

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

  Within 2 week after surgery.

Study Arms (1)

68Ga-MY6349 PET/CT

EXPERIMENTAL

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

Diagnostic Test: 68Ga-MY6349 PET/CT

Interventions

68Ga-MY6349 PET/CT DIAGNOSTIC_TEST

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

68Ga-MY6349 PET/CT

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Deling Li: lead
• Peking Union Medical College Hospital: collaborator

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Conditions

Craniopharyngioma; Disease

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Deling Li, MD

  Beijing Tiantan Hospital

  STUDY CHAIR

Central Study Contacts

Deling Li, MD

CONTACT

+86 13810098236; lideling@bjtth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 17, 2025
• Study Start: July 4, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

CN (1)