Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Dual Integrin αvβ3 and GRPR Targeting PET Imaging in Breast 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: NCT02749019
Recruitment Status : Unknown
Verified April 2016 by Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : April 22, 2016
Last Update Posted : April 22, 2016
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Peking Union Medical College Hospital

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 breast 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
Breast Cancer Drug: 68Ga-NOTA-BBN-RGD Phase 1

Detailed Description:
Gastrin-releasing peptide receptor (GRPR) is a member of the G protein-coupled receptor family of bombesin receptors, which is over-expressed in various types of cancer cells, including prostate cancer, breast cancer, colorectal cancer, pancreatic cancer, glioma, lung cancer, ovarian cancers, endometrial cancers, renal cell cancer and gastrointestinal stromal tumors. BBN(7-14), with the amino acid sequence of Gln-Trp-Ala-Val-Gly-His-Leu-Met-NH2, has been extensively used for the development of molecular probes for the imaging of GRPR. On the other hand, the RGD moiety binds with integrin αvβ3 receptor, also plays an important role in the regulation of tumor growth, angiogenesis, local invasiveness, and metastatic potential in human breast 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 breast cancer patients.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 68Ga-NOTA-BBN-RGD PET/CT in Breast Cancer Patients
Study Start Date : July 2015
Estimated Primary Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast 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 breast 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 breast cancer will be measured.

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.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Neoplasm identified by X-ray, ultrasound or MRI as breast cancer
  • To provide basic information and sign the written informed consent.

Exclusion Criteria:

  • Consisted of conditions of mental illness;
  • Severe liver or kidney disease with serum creatinine > 3.0 mg/dl (270 μΜ) or any hepatic enzyme level 5 times or more than normal upper limit;
  • Severe allergy or hypersensitivity to IV radiographic contrast
  • Claustrophobia to accept the PET/CT scanning
  • Pregnancy or breast feeding

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): NCT02749019

Layout table for location contacts
Contact: Zhaohui Zhu, MD. PhD. +86 10 69154196
Contact: Jingjing Zhang, MD. PhD +86 10 69155513

Layout table for location information
China, Beijing
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College Recruiting
Beijing, Beijing, China, 100730
Contact: Zhaohui Zhu, MD. PhD.    +86 10 69154196   
Sponsors and Collaborators
Peking Union Medical College Hospital
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Layout table for additonal information
Responsible Party: Peking Union Medical College Hospital Identifier: NCT02749019    
Other Study ID Numbers: PUMCHNM012
ZIAEB000073 ( U.S. NIH Grant/Contract )
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: April 2016
Keywords provided by Peking Union Medical College Hospital:
integrin αvβ3
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases