Craniopharyngioma
Conditions
Keywords
Positron-Emission Tomography, Diagnosis
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.
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_TEST68Ga-MY6349 PET/CT
Each subject receives a single intravenous injection of 68Ga-MY6349 and undergoes PET/CT imaging within the specified time.
Sponsors
Peking Union Medical College Hospital
Deling Li
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardized uptake value of 68Ga-MY6349 in PET imaging of craniopharyngioma | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
China
Contacts
Primary ContactDeling Li, MD
Outcome results
None listed