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Trial record 5 of 30 for:    cancer | First posted from 04/22/2016 to 04/22/2016

Dual Integrin αvβ3 and GRPR Targeting PET Imaging in Breast Cancer Patients

This study is currently recruiting participants.
Verified April 2016 by Peking Union Medical College Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02749019
First Posted: April 22, 2016
Last Update Posted: April 22, 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 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 Intervention Phase
Breast Cancer Drug: 68Ga-NOTA-BBN-RGD Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 68Ga-NOTA-BBN-RGD PET/CT in Breast 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 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.


Estimated Enrollment: 40
Study Start Date: July 2015
Estimated Primary Completion Date: July 2018 (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:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  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): NCT02749019


Contacts
Contact: Zhaohui Zhu, MD. PhD. +86 10 69154196 zhuzhh@pumch.cn
Contact: Jingjing Zhang, MD. PhD +86 10 69155513 zhangjingjing@pumch.cn

Locations
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    zhuzhh@pumch.cn   
Sponsors and Collaborators
Peking Union Medical College Hospital
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
  More Information

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02749019     History of Changes
Other Study ID Numbers: PUMCHNM012
ZIAEB000073 ( U.S. NIH Grant/Contract )
First Submitted: April 20, 2016
First Posted: April 22, 2016
Last Update Posted: April 22, 2016
Last Verified: April 2016

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases