Breast Carcinoma, Cancer of Head and Neck, Carcinoma, Bronchogenic, Lymphoma, Malignant, Soft Tissue Neoplasms, Tumors
Conditions
Brief summary
The purpose of this study is to determine whether 18F-Al labeled RGD is safety and effective for cancer diagnosis and therapy response.
Detailed description
Observe radiation dose to healthy volunteers and patients; the correlation between integrin level and tumor/metastases uptake.
Interventions
DRUG18F-Al-NOTA-PRGD2 PET/CT
18F-Al-NOTA-PRGD2(PET imaging agent) given by vein before PET scans.Perform PET/CT for each enrolled volunteer or patient at 60-90min.
Sponsors
Wuxi No. 4 People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Volunteers or patients with age more than 18 yeas; 2. The patients have been diagnosed with cancer or suspected with cancer; 3. It must fulfill the ethical requirements and subjects have signed an informed consent.
Exclusion criteria
1. Pregnancy or nursing mothers; 2. Having drugs or alcohol dependence; 3. Hypersensitive to the active or inactive ingredients of the study drug; 4. Having attended other drug clinical trials within three months; 5. Cardiac functional insufficiency; 6. Hepatic and renal function insufficiency; 7. Hypertensive patients with serious complications; 8. Endangering the safety of life.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety data included vital signs (blood pressure, respiratory rate, heart rate, and body temperature) (composite) | 1 day | Safety data were collected before and after injection of 18F-Al-NOTA-PRGD2. physical examination; ECG; laboratory parameters (blood routine, liver function and kidney function) and adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| radioactive distribution of normal organ, standard uptake value of tumor | 60 minutes | Visual analysis whole body 18F-Al-NOTA-PRGD2 PET;Regions of interest (ROIs) were drawn manually on each image with the assistance of corresponding CT images. The results were expressed as standardized uptake value (SUV). |
| Diagnostic performance analysis to assess sensitivity,specificity,accuracy,etc | 1 day-1 year | compare the Diagnostic outcome to pathology or clinic follow-up,then to gather statistics of sensitivity,specificity,accuracy,etc. |
Countries
China
Contacts
Primary ContactChunjing Yu, Dr.
Outcome results
None listed