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

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. Read our disclaimer for details. Identifier: NCT02747290
Recruitment Status : Unknown
Verified March 2016 by gwcmc.
Recruitment status was:  Recruiting
First Posted : April 21, 2016
Last Update Posted : April 21, 2016
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Drug: 68Ga-NOTA-BBN-RGD Early Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Study Start Date : July 2014
Estimated Primary Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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.
68Ga-NOTA-BBN-RGD were injected into the patients before the PET/CT scans

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.

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 identifier (NCT number): NCT02747290

Contact: Zhaohui Zhu, MD.PhD. +86 10 69154196
Contact: Jingjing Zhang, MD.PhD. +86 10 69155513

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

Responsible Party: gwcmc Identifier: NCT02747290     History of Changes
Other Study ID Numbers: PUMCHNM011
ZIAEB000073 ( U.S. NIH Grant/Contract )
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: March 2016

Keywords provided by gwcmc:
integrin αvβ3

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