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NCT Number: NCT07177482

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

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.

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Key information

Age range

14 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location status: Recruiting

Location contact

Deling Li, MD

CONTACT

[email protected]

+86 13810098236

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Within 1 week after PET imaging.

    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.

Secondary outcomes

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

    Time frame: Within 2 week after surgery.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Deling Li, MD

CONTACT

[email protected]

+86 13810098236

Sponsors and collaborators

Lead sponsor

Deling Li

Other

Collaborators

  • Peking Union Medical College Hospital

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 17, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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