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

Primary Purpose

Breast Neoplasms, Prostatic Neoplasms

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
18F-Al-NOTA-MATBBN PET/CT
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 Breast Neoplasms focused on measuring Breast Neoplasms,Prostatic Neoplasms

Eligibility Criteria

18 Years - undefined (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

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    18F-Al-NOTA-MATBBN PET/CT

    Arm Description

    Imaging with 18F-Al-NOTA-MATBBN PET/CT

    Outcomes

    Primary Outcome Measures

    Standardized uptake value of 18F-Al-NOTA-MATBBN in malignant lesions
    The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in malignant lesions will be measured.

    Secondary Outcome Measures

    Adverse events collection
    Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed.

    Full Information

    First Posted
    March 9, 2017
    Last Updated
    April 11, 2017
    Sponsor
    Wuxi No. 4 People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03094897
    Brief Title
    Clinic Study of 18F-Al-NOTA-MATBBN in Cancer Diagnostics
    Official Title
    Phase 1 Study of 18F-Al-NOTA-MATBBN in Cancer Diagnostics
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 20, 2017 (Anticipated)
    Primary Completion Date
    December 31, 2020 (Anticipated)
    Study Completion Date
    December 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether 18F-Al-NOTA-MATBBN is safety and effective for cancer diagnosis.
    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
    Breast Neoplasms, Prostatic Neoplasms
    Keywords
    Breast Neoplasms,Prostatic Neoplasms

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    18F-Al-NOTA-MATBBN PET/CT
    Arm Type
    Experimental
    Arm Description
    Imaging with 18F-Al-NOTA-MATBBN PET/CT
    Intervention Type
    Drug
    Intervention Name(s)
    18F-Al-NOTA-MATBBN PET/CT
    Intervention Description
    18F-Al-NOTA-MATBBN(PET imaging agent) given by vein before PET scans.Perform PET/CT for each enrolled volunteer or patient at 60-90min.
    Intervention Type
    Device
    Intervention Name(s)
    PET/CT
    Intervention Description
    Imaging with 18F-Al-NOTA-MATBBN PET/CT.
    Primary Outcome Measure Information:
    Title
    Standardized uptake value of 18F-Al-NOTA-MATBBN in malignant lesions
    Description
    The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in malignant lesions will be measured.
    Time Frame
    1 day
    Secondary Outcome Measure Information:
    Title
    Adverse events collection
    Description
    Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed.
    Time Frame
    1 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 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, PhD,MD
    Phone
    0510-88682783
    Email
    ycj_wxd1978@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    min Yang, PhD
    Phone
    0510-88682783
    Email
    ymzfk@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    chunjing Yu, PhD
    Organizational Affiliation
    Department of Nuclear Medicine, Affiliated Hospital of Jiangnan University (Wuxi 4th People's Hospital)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21233180
    Citation
    Honer M, Mu L, Stellfeld T, Graham K, Martic M, Fischer CR, Lehmann L, Schubiger PA, Ametamey SM, Dinkelborg L, Srinivasan A, Borkowski S. 18F-labeled bombesin analog for specific and effective targeting of prostate tumors expressing gastrin-releasing peptide receptors. J Nucl Med. 2011 Feb;52(2):270-8. doi: 10.2967/jnumed.110.081620. Epub 2011 Jan 13.
    Results Reference
    result

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

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