Clinic Study of 18F-Al-NOTA-PRGD2 in Cancer Diagnostics

Study Overview
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Brief Summary
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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
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Observe radiation dose to healthy volunteers and patients; the correlation between integrin level and tumor/metastases uptake.

Official Title
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Phase 1 Study of 18F-Al-NOTA-PRGD2 in Cancer Diagnostics

Conditions
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Breast Carcinoma, Tumors, Carcinoma, Bronchogenic, Cancer of Head and Neck, Lymphoma, Malignant, Soft Tissue Neoplasms

Intervention / Treatment
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* Drug: 18F-Al-NOTA-PRGD2 PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Volunteers or patients with age more than 18 yeas; The patients have been diagnosed with cancer or suspected with cancer; It must fulfill the ethical requirements and subjects have signed an informed consent. Exclusion Criteria: Pregnancy or nursing mothers; Having drugs or alcohol dependence; Hypersensitive to the active or inactive ingredients of the study drug; Having attended other drug clinical trials within three months; Cardiac functional insufficiency; Hepatic and renal function insufficiency; Hypertensive patients with serious complications; Endangering the safety of life.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-Al-NOTA-PRGD2 PET/CT<br>Imaging with 18F-Al-NOTA-PRGD2 PET/CT. | Drug: 18F-Al-NOTA-PRGD2 PET/CT<br>* 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.<br>* Other names: 18F-Alfatide II PET/CT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety data included vital signs (blood pressure, respiratory rate, heart rate, and body temperature) (composite) | 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radioactive distribution of normal organ, standard uptake value of tumor | 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). | 60 minutes | 
| Diagnostic performance analysis to assess sensitivity,specificity,accuracy,etc | compare the Diagnostic outcome to pathology or clinic follow-up,then to gather statistics of sensitivity,specificity,accuracy,etc. | 1 day-1 year |