VEGF Early Imaging for Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
C.P. Schroder, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT00991978
First received: October 7, 2009
Last updated: March 29, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Breast Cancer
Other: 89Zr-bevacizumab PET
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Vascular Endothelial Growth Factor (VEGF) Imaging for Early Breast Cancer Detection A Feasibility Study

Resource links provided by NLM:


Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • SUV in tumour and lymph nodes [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: March 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 89Zr-bevacizumab PET
89Zr-bevacizumab PET
Other: 89Zr-bevacizumab PET
PET-scan with 89Zr-bevacizumab
Other Name: 89Zr-bevacizumab

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991978

Locations
Netherlands
Universitar Medical Center Groningen
Groningen, Netherlands, 9713GZ
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
Principal Investigator: Caroline Schröder, MD PhD University Medical Centre Groningen
  More Information

Publications:
Responsible Party: C.P. Schroder, dr., University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT00991978     History of Changes
Other Study ID Numbers: VEGF early imaging
Study First Received: October 7, 2009
Last Updated: March 29, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University Medical Centre Groningen:
breast cancer
VEGF
Screening

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Endothelial Growth Factors
Bevacizumab
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014