VEGF Early Imaging for Breast Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 |
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| Netherlands | |
| Universitar Medical Center Groningen | |
| Groningen, Netherlands, 9713GZ | |
| 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 May 21, 2013