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

Sponsor
Wuxi No. 4 People's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02441972
Collaborator
(none)
200
Enrollment
1
Location
1
Arm
107
Duration (Months)
1.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: 18F-Al-NOTA-PRGD2 PET/CT
 Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Phase 1 Study of 18F-Al-NOTA-PRGD2 in Cancer Diagnostics
Study Start Date :
Jan 1, 2012
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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).

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wuxi No. 4 People's Hospital Wuxi Jiangsu China 214000

    Sponsors and Collaborators

    • Wuxi No. 4 People's Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wuxi No. 4 People's Hospital
    ClinicalTrials.gov Identifier:
    NCT02441972
    Other Study ID Numbers:
    • LS2011051
    First Posted:
    May 12, 2015
    Last Update Posted:
    Mar 10, 2017
    Last Verified:
    Dec 1, 2016
    Additional relevant MeSH terms:
    Carcinoma
    Breast Neoplasms
    Head and Neck Neoplasms
    Carcinoma, Bronchogenic
    Soft Tissue Neoplasms
    Lymphoma

    Study Results

    No Results Posted as of Mar 10, 2017