Neoplasms, Positron-Emission Tomography
Conditions
Brief summary
This study will investigate the safety and preliminary diagnostic efficacy of \[68Ga\]Ga-NOTA-T4 or \[18F\]AlF-RESCA-T4 in pancreatic cancer, breast cancer, head and neck cancer, lung cancers and other types of solid tumors. Then, this study will provide a new method for the noninvasive target-specific diagnosis of pancreatic cancer, breast cancer, head and neck cancer, lung cancers and other types of solid tumors. PET imaging of TROP-2 will be integrated to TROP-2-targeted therapies in some of the included patients. Therefore, PET imaging with \[68Ga\]Ga-NOTA-T4 or \[18F\]AlF-RESCA-T4 will help select patients for targeted therapy and monitor treatment responses after the treatment.
Interventions
RADIATION[68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4
The dose of \[68Ga\]Ga-NOTA-T4 or \[18F\]AlF-RESCA-T4 was calculated based on the patient's body weight to be 3.7 MBq \[0.1 mCi\]/kg, and the method of administration was intravenous push, with one single imaging administration.
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； 3. Renal function: serum creatinine less than or equal to the upper limit of the normal range;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. Those who have participated in other clinical trials during the same period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| evaluate the safety and feasibility of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT imaging in patients with solid tumors | 1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 | The primary goal of the study is to evaluate the distribution profiles (in terms of SUVmax) of \[68Ga\]Ga-NOTA-T4 or \[18F\]AlF-RESCA-T4 PET/CT imaging in patients with solid tumors. |
| evaluate the sensitivity and specificity of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT for visualizing TROP-2 expression | 1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 | The secondary goal is to evaluate the sensitivity and specificity of \[68Ga\]Ga-NOTA-T4 or \[18F\]AlF-RESCA-T4 PET/CT for visualizing TROP-2 expression. |
| evaluate the value of TROP-2 expression determined by [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 PET/CT | 1 hour after injection of [68Ga]Ga-NOTA-T4 or [18F]AlF-RESCA-T4 | The third goal is to evaluate the value of TROP-2 expression determined by \[68Ga\]Ga-NOTA-T4 or \[18F\]AlF-RESCA-T4 PET/CT in differential diagnosis, patient selection, and response monitoring in patients with solid tumors. |
Countries
China
Contacts
Primary ContactYihui Guan, MD
Outcome results
None listed