In the present study, we aim to perform a feasibility study to prove that 89Zirconium-bevacizumab PET scanning can indeed detect all small primary breast cancer lesions. Data from the present study may be used to design further studies with regard…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint will be 89Zr-bevacizumab tracer uptake in primary breast
tumors
Secondary outcome
The secondary endpoint will be 89Zr-bevacizumab tracer uptake in axillary lymph
nodes.
Background summary
Screening mammography is nowadays the single most effective method of early
breast cancer detection. For screening of high risk individuals, 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.
Developing innovative visualization techniques based on essential alterations
in breast cancer cells, are clearly desirable for optimizing early diagnosis of
breast cancer. VEGF is a potent angiogenic growth factor, commonly involved in
tumor-induced angiogenesis and is differentially expressed in normal versus
(pre)malignant breast tissue. Non-invasive assessment of VEGF-levels in the
micro-environment of the pre-malignant or malignant breast tumor could
potentially be used as screening tool.
Study objective
In the present study, we aim to perform a feasibility study to prove that
89Zirconium-bevacizumab PET scanning can indeed detect all small primary breast
cancer lesions. Data from the present study may be used to design further
studies with regard to early breast cancer detection, and can potentially
support development of fluorescent optical imaging of VEGF as a screenings tool.
Primary objective
The aim is to perform a feasibility study to show that VEGF PET imaging using
89Zr-bevacizumab as tracer can be used for early breast cancer detection.
Secondary Objectives
A secondary aim is whether positive lymph nodes can be detected.
Study design
All patients will undergo a 89Zr-bevacizumab PET scan preoperatively at day 4
following tracer injection. The uptake of 89Zr-bevacizumab in the tumor will
be quantified. Results will be fused and compared with standard imaging
techniques and with standard tumor histology as well as specific tumor
stainings for angiogenesis including VEGF staining. Sensitivity and specificity
will be compared with conventional imaging.
Study burden and risks
There is a small change the patient devellops an allergic reaction on the
tracer. Furthermore, a patient can devellop a haemotoma afer injection.
Potbus 30.001
9700 RB Groningen
NL
Potbus 30.001
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
Patients with a breast tumor who are scheduled to receive operative intervention either by means of a mastectomy or lumpectomy
Exclusion criteria
• Other invasive malignancy or condition which could affect compliance with the protocol or interpretation of results.
• Pregnant or lactating women.
• 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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-015838-29-NL |
| Other | n.a. |
| CCMO | NL29473.042.09 |