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VEGF Early Imaging for Breast Cancer

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: NCT00991978
Recruitment Status : Completed
First Posted : October 8, 2009
Last Update Posted : March 30, 2012
Information provided by (Responsible Party):
C.P. Schroder, University Medical Center Groningen

Brief Summary:

Breast cancer is the most common cause of cancer death among women. Yearly around 12,500 Dutch women are diagnosed with breast cancer and 3,500 die of this disease. One of the problems leading to such striking effect refers to late tumor detection due to inadequate sensitivity of current imaging techniques. Current screening is performed by means of mammography, consisting of traditional film-screen mammograms of digital mammograms. These digital mammograms offer digital enhancement to aid interpretation, which is especially helpful in women with dense breast tissue. Screening mammography is nowadays the single most effective method of early breast cancer detection. For screening of high risk individuals, increasingly the magnetic resonance imaging (MRI) technique is emerging. However, none of the above mentioned techniques has an optimal sensitivity and specificity, leading for instance to a significant portion of false positive results. The clinical consequence of this error is that additional tests and procedures are performed in women who may not have cancer. In the United States, for example, 11% mammograms require additional evaluation; the lesion turns out to be benign in more than 90% of cases [1].

False-positive readings False positive readings are more common in younger women, both because the tests are less specific and because breast cancer is less common [2,3]. As a result, more follow-up procedures, including invasive procedures such as biopsies, will be done in younger women even though fewer cancers will be found. Furthermore, because breast cancer screening occurs repeatedly, the risk of a false-positive study is likely to rise with repeated screening [4].

Emerging adjuncts to mammography include ultrasonography, which is helpful for further assessment of known areas of interest, and magnetic resonance imaging. Image-guided biopsy - directed by ultrasonography or stereotactic mammography views - plays a critical role in histological confirmation of suspected breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: 89Zr-bevacizumab PET Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Vascular Endothelial Growth Factor (VEGF) Imaging for Early Breast Cancer Detection A Feasibility Study
Study Start Date : March 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: 89Zr-bevacizumab PET
89Zr-bevacizumab PET
Other: 89Zr-bevacizumab PET
PET-scan with 89Zr-bevacizumab
Other Name: 89Zr-bevacizumab

Primary Outcome Measures :
  1. SUV in tumour and lymph nodes [ Time Frame: 4 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with a breast tumor size < 2 cm in diameter (as determined by means of conventional imaging techniques: mammography, ultrasound or MRI) who are scheduled to receive operative intervention either by means of a mastectomy or lumpectomy.
  • histologically proven breast cancer
  • Age > 18 years.
  • WHO performance status 0-2 (see: appendix B)
  • Signed written informed consent (approved by the Institutional Review Board [IRB]/ Independent Ethics Committee [IEC]) obtained prior to any study specific screening procedures.
  • Able to comply with the protocol.

Exclusion Criteria:

  • Other invasive malignancy or condition which could affect compliance with the protocol or interpretation of results.
  • Pregnant or lactating women. Documentation of a negative pregnancy test must be available for pre-menopausal women with intact reproductive organs and for women less than two years after menopause.
  • Prior radiotherapy on the involved area.
  • Major surgery within 28 days before the initiation of the study.
  • Clinically significant cardiovascular disease.
  • Prior allergic reaction to immunoglobulins or immunoglobulin allergy.

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): NCT00991978

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Universitar Medical Center Groningen
Groningen, Netherlands, 9713GZ
Sponsors and Collaborators
University Medical Center Groningen
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Principal Investigator: Caroline Schröder, MD PhD University Medical Center Groningen
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Responsible Party: C.P. Schroder, dr., University Medical Center Groningen Identifier: NCT00991978    
Other Study ID Numbers: VEGF early imaging
First Posted: October 8, 2009    Key Record Dates
Last Update Posted: March 30, 2012
Last Verified: March 2012
Keywords provided by C.P. Schroder, University Medical Center Groningen:
breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Molecular Mechanisms of Pharmacological Action