Colorectal Neoplasms, Positron-Emission Tomography
Conditions
Brief summary
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.
Interventions
RADIATION[68Ga]Ga-NOTA-WWH347 or [18F]F-H3RESCA-WWH347
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.
Sponsors
Huashan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Be between 18 and 65 years of age and of either sex. 2. Patients with colorectal cancer confirmed by puncture or surgical pathology. 3. Written informed consent signed by the subject or legal guardian or caregiver. 4. Willingness and ability to cooperate with all programs of this study.
Exclusion criteria
1. Severe hepatic or renal insufficiency; 2. Targeted therapy before radiotherapy or PET/CT scan. Renal function: serum creatinine less than or equal to the upper limit of the normal range; 3. Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range. 4. History of serious surgery in the last month. 5. Those who have participated in other clinical trials during the same period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Establishment and optimization of imaging method for [68Ga]Ga-NOTA-WWH347 or [18F]F-H3RESCA-WWH347 PET/CT. | 90mins from time of injection | To assess the safety, sensitivity and specificity of diagnosing colorectal cancer using \[68Ga\]Ga-NOTA-WWH347 or \[18F\]F-H3RESCA-WWH347 PET/CT. |
Countries
China
Contacts
Primary ContactYihui Guan, MD
Outcome results
None listed