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| Name | Class |
|---|---|
| Tianjin Medical University Cancer Institute and Hospital | OTHER |
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This clinical trial is a single-center, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics and radiation dosimetry of 68Ga-NODAGA-SNA009 in patients with colorectal cancer.
68Ga-NODAGA-SNA009 is a radiopharmaceutical that targets GPA33. This study aims to assess the correlation between radiological imaging results and the pathological expression of GPA33.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1 | Experimental | 0.1mg |
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| Group 2 | Experimental | 0.3mg |
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| Group 3 | Experimental | 0.5mg |
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| Group 4 | Experimental | 0.9mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-NODAGA-SNA009 | Drug | 68Ga-NODAGA-SNA009 is a radiopharmaceutical agents that targets GPA33 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The safety and tolerability in patients with advanced colorectal cancer. | Occurrence of AE/SAE according to CTCAE 5.0 | 1 week |
| The safety and tolerability in patients with advanced colorectal cancer. | Occurrence of abnormal Laboratory tests after administration | 1 week |
| The safety and tolerability in patients with advanced colorectal cancer. | Occurrence of abnormal Vital signs after administration | 1 week |
| The safety and tolerability in patients with advanced colorectal cancer. | Occurrence of abnormal Physical examination after administration | 1 week |
| The safety and tolerability in patients with advanced colorectal cancer. | Occurrence of abnormal ECG after administration | 1 week |
| The radiation characters in patients with colorectal cancer | radiological absorption dose of major organs | 4 hours |
| The biodistribution characteristics of 68Ga-NODAGA-SNA009 | SUVmax of major organs and tumors | 4 hours |
| The biodistribution characteristics of 68Ga-NODAGA-SNA009 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between imaging and IHC | Correlation of tumors between 68Ga-NODAGA-SNA009 in PET imaging and GPA33 expression levels in patients with colorectal cancer. | 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300000 | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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SUVmean of major organs and tumors
| 4 hours |
| The biodistribution characteristics of 68Ga-NODAGA-SNA009 | Retention time of major organs and tumors | 4 hours |
| The biodistribution characteristics of 68Ga-NODAGA-SNA009 | Percentage of injection dose (ID%) of major organs and tumors | 4 hours |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |