Fine Needle Aspiration Improvements Team Members Janie Goldsworthy Kristi Hinner Nick Kortan Crystal Marshek Client Dr Elizabeth Burnside Assistant Professor Chief Breast Imaging Advisor Professor John Webster December 12 2002 Abstract The following document presents our final design to modify the current fine needle aspiration FNA procedure used to diagnose abnormal cells in breast tissue FNA is one of four commonly performed techniques used to remove tissue or cells during a breast biopsy Often a sample taken using FNA is declared insufficient by the cytologist doing the analysis This can be due to either lack of cells or the cells obtained remain in a clump which makes analysis difficult It is for this reason that there is an attempt being made to modify the needle used to perform the FNA in the hopes that the modifications will increase the amount of material exhumed from the site in the breast as well as to break up the cells that are removed An increase in material would allow the cytologist to diagnose the cells or tissue with only one FNA attempt Currently multiple attempts need to be made before adequate material is removed The needle design chosen is a microdrill bit insert which has been tested on fixed tissue samples to allow for evaluation of the technique s success Results were promising after two series of tests Table of Contents Page Number Client Statement 3 Background information Techniques FNA Biopsy Procedure Other Needle Manufacturers 3 4 5 6 6 Design Constraints 6 Alternative Design Solutions 6 8 Final Design Solution 8 10 Future Plans 10 12 Conclusion 12 Appendix PDS Mammography Ultrasound Testing Procedure 13 15 16 17 18 References 19 2 Client Statement Dr Elizabeth Burnside assistant professor and chief of breast imaging performs between one and four breast biopsies each day Two biopsy methods often used by Dr Burnside are core biopsy and fine needle aspiration FNA While core biopsy almost always obtains sufficient samples it poses many disadvantages One disadvantage is that it is a more invasive procedure 4 Second a loud noise occurs during the procedure which can scare the patient and third if the mass is found near the ribs there may be a risk of internal injury to the ribs due to this procedure FNA is the least invasive method for breast biopsies and is most comfortable and affordable for the patient given that the first sample is sufficient However FNA is often unsuccessful due to the difficulty of retrieving a sufficient sample through a small needle approximately 20 gauge When an insufficient sample is obtained either the FNA procedure is repeated or a more invasive biopsy method such as core biopsy or vacuum assisted biopsy is performed The waiting involved with repetition of the FNA procedure often adds to a patient s already heightened anxiety As a result of the insufficient samples associated with FNA many physicians are straying away from this minimally invasive technique Dr Burnside would like us to modify the current FNA needle Inrad Aspiration Biopsy Needle by developing a small needle with a unique tip or insert that would maximize the tissue obtained and increase the diagnostic yield of this very valuable procedure Background Information Techniques There are approximately four needle aspiration procedures performed to remove tissue or cells Each procedure differs in how it is performed the equipment used and the type and amount of tissue it removes The four procedures are fine needle aspiration core needle biopsy vacuumassisted biopsy and large core biopsy The fine needle aspiration Figure 1 procedure is fast minimally painful and involves no incision The surgeon uses a fine hollow needle that is sometimes attached to a syringe to extract fluid from a cyst or cells from a solid lesion Once the needle is removed the sample is delivered to a cytologist who immediately analyzes the sample Often the cytologist declares the sample as insufficient lacking a large enough number of cells in question in which case the physician either repeats the FNA procedure or uses the core biopsy procedure to obtain a larger sample 4 In the case that the sample is sufficient the cytologist will declare the sample as cancer or fibrinoma non cancerous Often the patient will be informed of the test results before leaving Figure 1 Fine needle aspiration http www imaginis com breasthealth biopsy fine 3 Core needle biopsy Figure 2 is similar to fine needle aspiration but the needle is larger enabling a larger sample to be obtained It is performed under local anesthesia and ultrasound Appendix C or mammography Appendix B is used if the lump cannot be felt Three to six needle insertions are needed to obtain an adequate sample of tissue 13 A loud clicking sound may be heard as the samples are being taken and the patient may feel some pressure but should not feel pain The procedure takes a few minutes and no stitches are required Core needle biopsy may provide a more accurate analysis and diagnosis than fine needle aspiration because tissue is removed rather than just cells This procedure is not accurate in patients with very small or hard lumps 3 13 Figure 2 Core needle biopsy http www imaginis com breasthealth biopsy fine Vacuum assisted biopsy Figure 3 utilizes a vacuum like device to remove breast tissue Local anesthesia is used and no incision is made Mammography is used to guide a breast probe to the lesion Computers pinpoint the mass and suction draws out the breast tissue The needle is inserted once to obtain multiple samples In some cases the entire lesion may be removed Vacuum assisted biopsy is safe reliable and valuable for patients who are not candidates for other minimally invasive biopsy techniques and those who wish to avoid surgical biopsy 9 13 Figure 3 Vacuum assisted Biopsy http www imaginis com breasthealth biopsy fine Large core biopsy also called advanced breast biopsy instrumentation ABBI shown in Figure 4 is an alternative for patients who prefer a less invasive procedure than surgery Large core biopsy is able to remove a sizeable specimen or an entire lesion using a surgical device and mammography It combines wire needle localization and the ability to remove a tissue specimen and allows the sample to be removed in one piece After the region is numbed using a local anesthetic the localizing needle is guided to the lesion A very small incision is made and a cannula i e a tube and a cutting device is passed through the incision Breast tissue is