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

Phase 1

• Conditions: Lymphoma, Malignant; Cancer of Head and Neck; Tumors; Carcinoma, Bronchogenic; Breast Carcinoma; Soft Tissue Neoplasms
• Interventions: Drug: 18F-Al-NOTA-PRGD2 PET/CT

• Registration Number: NCT02441972
• Lead Sponsor: Wuxi No. 4 People's Hospital

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2015-04-21
• Study First Submitted QC: 2015-05-11
• Study First Posted: 2015-05-12
• Status Verified: 2016-12
• Last Update Submitted: 2017-03-09
• Last Update Posted: 2017-03-10
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-Al-NOTA-PRGD2 PET/CT	18F-Al-NOTA-PRGD2 PET/CT	Imaging with 18F-Al-NOTA-PRGD2 PET/CT.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Wuxi No. 4 People's Hospital; 🇨🇳 Wuxi, Jiangsu, China