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

March 9, 2017 updated by: Wuxi No. 4 People's Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Wuxi, Jiangsu, China, 214000
        • Recruiting
        • Wuxi No. 4 People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 18F-Al-NOTA-PRGD2 PET/CT
Imaging with 18F-Al-NOTA-PRGD2 PET/CT.
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.
Other Names:
  • 18F-Alfatide II PET/CT

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuxi No. 4 People's Hospital

Investigators

  • Study Chair: Weixing Wan, Professor, Wuxi No. 4 People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

April 21, 2015

First Submitted That Met QC Criteria

May 11, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Actual)

March 10, 2017

Last Update Submitted That Met QC Criteria

March 9, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LS2011051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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