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

Primary Purpose

Tumors, Carcinoma, Bronchogenic, Breast Carcinoma

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
18F-Al-NOTA-PRGD2 PET/CT
Sponsored by
Wuxi No. 4 People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Tumors

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Wuxi No. 4 People's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-Al-NOTA-PRGD2 PET/CT

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.

Full Information

First Posted
April 21, 2015
Last Updated
March 9, 2017
Sponsor
Wuxi No. 4 People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02441972
Brief Title
Clinic Study of 18F-Al-NOTA-PRGD2 in Cancer Diagnostics
Official Title
Phase 1 Study of 18F-Al-NOTA-PRGD2 in Cancer Diagnostics
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuxi No. 4 People's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumors, Carcinoma, Bronchogenic, Breast Carcinoma, Cancer of Head and Neck, Lymphoma, Malignant, Soft Tissue Neoplasms

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
18F-Al-NOTA-PRGD2 PET/CT
Arm Type
Experimental
Arm Description
Imaging with 18F-Al-NOTA-PRGD2 PET/CT.
Intervention Type
Drug
Intervention Name(s)
18F-Al-NOTA-PRGD2 PET/CT
Other Intervention Name(s)
18F-Alfatide II PET/CT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety data included vital signs (blood pressure, respiratory rate, heart rate, and body temperature) (composite)
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
radioactive distribution of normal organ, standard uptake value of tumor
Description
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).
Time Frame
60 minutes
Title
Diagnostic performance analysis to assess "sensitivity,specificity,accuracy,etc"
Description
compare the Diagnostic outcome to pathology or clinic follow-up,then to gather statistics of sensitivity,specificity,accuracy,etc.
Time Frame
1 day-1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunjing Yu, Dr.
Phone
86-15312238622
Email
ycj_wxd1978@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weixing Wan, Professor
Organizational Affiliation
Wuxi No. 4 People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Wuxi No. 4 People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunjing Yu, M.D.
Phone
15312238622
Email
ycj_wxd1978@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
16818691
Citation
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. Clin Cancer Res. 2006 Jul 1;12(13):3942-9. doi: 10.1158/1078-0432.CCR-06-0266.
Results Reference
result
PubMed Identifier
18077538
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-RGD and 18F-FDG. J Nucl Med. 2008 Jan;49(1):22-9. doi: 10.2967/jnumed.107.045864. Epub 2007 Dec 12.
Results Reference
result

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

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