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| Name | Class |
|---|---|
| Peking Union Medical College Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-MY6349 PET/CT | Experimental | Each subject receives a single intravenous injection of 68Ga-MY6349 and undergoes PET/CT imaging within the specified time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the feasibility of PET/CT imaging with 68Ga-MY6349 for the non-invasive assessment of Trop2 expression in craniopharyngioma. | 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. | Within 2 week after surgery. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deling Li, MD | Contact | +86 13810098236 | lideling@bjtth.org |
| Name | Affiliation | Role |
|---|---|---|
| Deling Li, MD | Beijing Tiantan Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Recruiting | Beijing | Beijing Municipality | 100070 | China |
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| ID | Term |
|---|---|
| D003397 | Craniopharyngioma |
| D004194 | Disease |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| D009380 | Neoplasms, Nerve Tissue |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |