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This study is to evaluate the safety, biodistribution, radiation dosimetry and tumor uptake of the [68Ga]/ [131I]-IR199 in patients with Claudin 18.2 positive gastric cancer and pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [68Ga]/ [131I]-IR199, single dose | Experimental | [68Ga]/ [131I]-IR199, single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [68Ga]/ [131I]-IR199 | Drug | [68Ga]/ [131I]-IR199, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absorbed radiation dose (Gy) distribution in normal organs and tumors by quantitative SPECT/CT dosimetry | Absorbed radiation dose (Gy) distribution in normal organs and tumors by quantitative SPECT/CT dosimetry | about 24 hours from time of injection, about 48 hours from time of injection and about 72 hours from time of injection |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Assessment | Incidence and severity of adverse events (AEs) as assessed by CTCAE v6.0 | From administration of [68Ga]/ [131I]-IR199 until 1 week after injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yihui Guan, MD | Contact | +86 13764308300 | guanyihui@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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