ImmunoPET Targeting Trophoblast Cell-surface Antigen 2 (Trop-2) in Craniopharyngioma Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 68Ga-MY6349 PET/CT.
- Who it may be relevant to
- Registry conditions: Craniopharyngioma. Basic parameters: 14 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Detailed 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.
Interventions
- Diagnostic test 68Ga-MY6349 PET/CT
Each subject receives a single intravenous injection of 68Ga-MY6349 and undergoes PET/CT imaging within the specified time.
Primary outcome measures
- Standardized uptake value of 68Ga-MY6349 in PET imaging of craniopharyngioma [Time frame: Within 1 week after PET imaging.]
Secondary outcome measures (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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Beijing Tiantan Hospital — Beijing
Identifiers
NCT: NCT07177482 · BTHospital-N-010