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Trial record 2 of 22 for:    cancer | First posted from 04/21/2016 to 04/21/2016

68Ga-NOTA-BBN-RGD PET/CT in Prostate Cancer Patients

This study is currently recruiting participants.
Verified March 2016 by Peking Union Medical College Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02747290
First Posted: April 21, 2016
Last Update Posted: April 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Peking Union Medical College Hospital
  Purpose
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-BBN-RGD in prostate cancer patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-BBN-RGD will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.

Condition Intervention Phase
Prostate Cancer Drug: 68Ga-NOTA-BBN-RGD Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Safety and Diagnostic Performance of 68Gallium-labeled NOTA-BBN-RGD PET/CT in Prostate Cancer Patients

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • Standardized uptake value of 68Ga-NOTA-BBN-RGD in prostate cancer [ Time Frame: 1 year ]
    The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in prostate cancer will be measured.


Secondary Outcome Measures:
  • Adverse events collection [ Time Frame: 1 week ]
    Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed.


Estimated Enrollment: 30
Study Start Date: July 2014
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 68Ga-NOTA-BBN-RGD PET/CT
The patients were injected with 111-148 MBq of 68Ga-NOTA-BBN-RGD in one dose intravenously and underwent PET/CT scan 15-30 min later.
Drug: 68Ga-NOTA-BBN-RGD
68Ga-NOTA-BBN-RGD were injected into the patients before the PET/CT scans

Detailed Description:
Both GRPR and integrin αvβ3 are overexpressed in neoplastic cells of human prostate cancer. To target both receptors, a heterodimeric peptide BBN-RGD was synthesized from bombesin(7-14) and c(RGDyK) through a glutamate linker and then labeled with 68Ga. An open-label whole-body PET/ CT study was designed to investigate the safety and dosimetry of 68Ga-NOTA-BBN-RGD and diagnostic performance of 68Ga-NOTA-BBN-RGD PET/CT in patients with primary and/or metastasis prostate cancer.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must be able to provide a written informed consent, needle biopsy diagnosed as prostate cancer, have undergone whole body bone scan, able to provide basic information and sign the written informed consent.

Exclusion Criteria:

  • The exclusion criteria included claustrophobia, kidney or liver failure, and inability to fulfill the study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02747290


Contacts
Contact: Zhaohui Zhu, MD.PhD. +86 10 69154196 13611093752@163.com
Contact: Jingjing Zhang, MD.PhD. +86 10 69155513 zhangjingjingtag@163.com

Locations
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Jingjing Zhang, MD.    +86 10 69155513    zhangjingjingtag@163.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Investigators
Study Chair: Fang Li, MD. Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
  More Information

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02747290     History of Changes
Other Study ID Numbers: PUMCHNM011
ZIAEB000073 ( U.S. NIH Grant/Contract )
First Submitted: April 19, 2016
First Posted: April 21, 2016
Last Update Posted: April 21, 2016
Last Verified: March 2016

Keywords provided by Peking Union Medical College Hospital:
BBN-RGD
PET
integrin αvβ3
GRPR

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases