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This is a prospective, single-center study aimed at evaluating the uptake characteristics of 68Ga-NYM096 PET/CT in various kinds of tumors including primary and metastatic lesions. Based on image analysis, this study will assess the uptake of various kinds of tumors using 68Ga-NYM096 PET/CT. The findings will provide critical insights into the tumor uptake on 68Ga-NYM096 PET/CT to identify the most promising indications for future application.
This is a prospective, single-center study designed to evaluate the uptake characteristics of 68Ga-NYM096 PET/CT in various kinds of tumors including primary and metastatic lesions. Each patient will receive a single intravenous dose of 68Ga-NYM096, followed by dedicated whole-body PET/CT imaging. 68Ga-NYM096 PET/CT scans were requested by referring physicians according to individual clinical indications that were considered insufficiently covered by 18F-FDG PET/CT or other imaging modalities.
Quantitative analyses will be applied to assess the uptake of 68Ga-NYM096 in primary and metastatic lesions in different tumor types, including lesion number, SUVmax (40% isocontour), tumor-to-background ratio (TBR).
120 patients with histopathologically proven primary tumors or metastases or radiologically unequivocal metastatic lesions of histologically proven primary tumors will be recruited in Peking Union Medical College Hospital. This study will be conducted according to local regulations and laws, the ethical principles that have their origin in the Declaration of Helsinki, and the principles of Good Clinical Practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-NYM096 PET/CT | Experimental | Each patient will receive one dose of 68Ga-NYM096 by intravenous route. Dedicated whole-body PET/CT imaging will be performed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-NYM096 PET/CT | Other | Participants will be administered a single, intravenous bolus of 68Ga-NYM096 The recommended administered activity of 68Ga-NYM096 is 1.8-2.2 MBq per kilogram bodyweight, subject to variation that may be required owing to variable elution efficiencies obtained during the lifetime of the 68Ga / 68Ga generator. The CT and PET imaging session will begin approximately 45 to 75 minutes after 68Ga-NYM096 administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Uptake characteristics (quantitative analysis) of tumor lesions including primary and metastatic lesions identified on 68Ga-NYM096 PET/CT | For tumor lesions, the tracer uptake is quantified using maximal and mean standard uptake value by drawing a 3-dimensional region of interest (ROI) over the lesion using a threshold of 40% SUVmax. Tumor-to-background ratios (TBRs) should also be evaluated. Adjacent normal tissue is the preferred background tissue. If not available, the blood pool should be designated as background tissue. | From study completion to 1 month after completion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Huo, MD | Contact | +86 18612672038 | huoli@pumch.cn | |
| Wenjia Zhu, MD | Contact | +86 18614080164 | zhuwenjia_pumc@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital, Beijing, Beijing 100730 | Recruiting | Beijing | 100730 | China |
Available upon request
Within 2 years after the publication of the main results
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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