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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02441972
• Other study ID #: LS2011051
• Status: Recruiting
• Phase: Phase 1
• First received: April 21, 2015
• Last updated: March 9, 2017
• Start date: January 2012
• Est. completion date: December 2020

Study information

• Verified date: December 2016
• Source: Wuxi No. 4 People's Hospital
• Contact: Chunjing Yu, Dr.
• Phone: 86-15312238622
• Email: ycj_wxd1978[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether 18F-Al labeled RGD is safety and effective for cancer diagnosis and therapy response.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• 18F-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.

Locations

Country	Name	City	State
China	Wuxi No. 4 People's Hospital	Wuxi	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Wuxi No. 4 People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Beer AJ, Haubner R, Sarbia M, Goebel M, Luderschmidt S, Grosu AL, Schnell O, Niemeyer M, Kessler H, Wester HJ, Weber WA, Schwaiger M. Positron emission tomography using [18F]Galacto-RGD identifies the level of integrin alpha(v)beta3 expression in man. Cli — View Citation

Beer AJ, Lorenzen S, Metz S, Herrmann K, Watzlowik P, Wester HJ, Peschel C, Lordick F, Schwaiger M. Comparison of integrin alphaVbeta3 expression and glucose metabolism in primary and metastatic lesions in cancer patients: a PET study using 18F-galacto-RG — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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