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In this study, we will first investigate the imaging safety and feasibility of [68Ga]Ga-NOTA-WWH347 and [18F]F-H3RESCA-WWH347 PET/CT in patients with primary and/or metastatic colorectal cancers. The second goal of the study is to preliminarily investigate the diagnostic efficacy (e.g., sensitivity and specificity) of [68Ga]Ga-NOTA-WWH347 and [18F]F-H3RESCA-WWH347 PET/CT in patients with primary and/or metastatic colorectal cancers. This study will provide a new method for the noninvasive target-specific diagnosis of colorectal cancer, and provide an intuitive and clear imaging basis for clinical diagnosis, differential diagnosis and treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with colorectal cancer | Experimental | Subjects were recruited from the Department of Gastroenterology, Huashan Hospital, Fudan University, Shanghai, China. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [68Ga]Ga-NOTA-WWH347 or [18F]F-H3RESCA-WWH347 | Radiation | The dose of [68Ga]Ga-NOTA-WWH347 or [18F]F-H3RESCA-WWH347, calculated from the patient's body weight, was 1.8-3.7 MBq [0.05-0.1 mCi]/kg, and was administered as an intravenous push, with a single dose given once. |
| Measure | Description | Time Frame |
|---|---|---|
| Establishment and optimization of imaging method for [68Ga]Ga-NOTA-WWH347 or [18F]F-H3RESCA-WWH347 PET/CT. | To assess the safety, sensitivity and specificity of diagnosing colorectal cancer using [68Ga]Ga-NOTA-WWH347 or [18F]F-H3RESCA-WWH347 PET/CT. | 90mins from time of injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yihui Guan, MD | Contact | 13764308300 | +86 | guanyihui@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Fang Xie, PhD | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital | Recruiting | Shanghai | 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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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |