VEGF Early Imaging for Breast Cancer

NCT00991978 | Completed Early Phase 1 DMC

• 1 other identifier: VEGF early imaging
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer; VEGF; Screening

Outcome Measures

Primary Outcomes (1)

• SUV in tumour and lymph nodes

  4 days

Study Arms (1)

89Zr-bevacizumab PET

EXPERIMENTAL

89Zr-bevacizumab PET

Other: 89Zr-bevacizumab PET

Interventions

89Zr-bevacizumab PET OTHER

PET-scan with 89Zr-bevacizumab

Also known as: 89Zr-bevacizumab

89Zr-bevacizumab PET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

Universitar Medical Center Groningen

Groningen, Provincie Groningen, 9713GZ, Netherlands

Location

Related Publications (6)

• Brown ML, Houn F, Sickles EA, Kessler LG. Screening mammography in community practice: positive predictive value of abnormal findings and yield of follow-up diagnostic procedures. AJR Am J Roentgenol. 1995 Dec;165(6):1373-7. doi: 10.2214/ajr.165.6.7484568.

  PMID: 7484568 BACKGROUND

• Kerlikowske K, Grady D, Barclay J, Sickles EA, Eaton A, Ernster V. Positive predictive value of screening mammography by age and family history of breast cancer. JAMA. 1993 Nov 24;270(20):2444-50.

  PMID: 8230621 BACKGROUND

• Lidbrink E, Elfving J, Frisell J, Jonsson E. Neglected aspects of false positive findings of mammography in breast cancer screening: analysis of false positive cases from the Stockholm trial. BMJ. 1996 Feb 3;312(7026):273-6. doi: 10.1136/bmj.312.7026.273.

  PMID: 8611781 BACKGROUND

• Eddy DM. Screening for breast cancer. Ann Intern Med. 1989 Sep 1;111(5):389-99. doi: 10.7326/0003-4819-111-5-389.

  PMID: 2504094 BACKGROUND

• Sledge GW Jr. VEGF-targeting therapy for breast cancer. J Mammary Gland Biol Neoplasia. 2005 Oct;10(4):319-23. doi: 10.1007/s10911-006-9005-5.

  PMID: 16924373 BACKGROUND

• Kataoka N, Cai Q, Wen W, Shu XO, Jin F, Gao YT, Zheng W. Population-based case-control study of VEGF gene polymorphisms and breast cancer risk among Chinese women. Cancer Epidemiol Biomarkers Prev. 2006 Jun;15(6):1148-52. doi: 10.1158/1055-9965.EPI-05-0871.

  PMID: 16775174 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

89Zr-bevacizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Caroline Schröder, MD PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr.

Study Record Dates

• First Submitted: October 7, 2009
• First Posted: October 8, 2009
• Study Start: March 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: March 30, 2012

Record last verified: 2012-03

Locations

NL (1)