X-ray Text of an interventional: shows new imaging system may cut X-ray exposure for liver cancer patients

X-ray Text of an interventional: shows new imaging system may cut X-ray exposure for liver cancer patients

Johns Hopkins researchers report that their test of an interventional X-ray guidance device approved by the U.S. Food and Drug Administration in 2013 has the potential to reduce the radiation exposure of patients undergoing intra-arterial therapy (IAT) for liver cancer.

3-D mammography improves cancer detection in dense breasts

3-D mammography improves cancer detection in dense breasts

A major new study being presented at the annual meeting of the Radiological Society of North America (RSNA) has found that digital breast tomosynthesis, also known as 3-D mammography, has the potential to significantly increase the cancer detection rate in mammography screening of women with dense breasts.

Breasts are considered dense if they have a lot of fibrous or glandular tissue but not much fatty tissue. Research has shown that dense breasts are more likely to develop cancer, a problem compounded by the fact that cancer in dense breasts can be difficult to detect on mammograms.
Other imaging modalities like ultrasound and MRI are often used to help find cancers that can't be seen on mammograms, but both modalities have higher rates of false-positive findings, which are suspicious findings that turn out not to be cancer. This higher false-positive rate often results in more tests and unnecessary biopsies, making MRI and ultrasound expensive to implement in high-volume screening programs, according to study lead author Per Skaane, M.D., Ph.D., from the Department of Radiology at Oslo University Hospital in Oslo, Norway.

Dr. Skaane and colleagues have been studying tomosynthesis as a promising breast cancer screening option that addresses some of the limitations of mammography by providing 3-D views of the breast.
"Tomosynthesis could be regarded as an improvement of mammography and would be much easier than MRI or ultrasound to implement in organized screening programs," Dr. Skaane said. "So the intention of our study was to see if tomosynthesis really would significantly increase the cancer detection rate in a population-based mammography screening program."

The researchers compared cancer detection using full-field digital mammography (FFDM) versus FFDM plus digital breast tomosynthesis in 25,547 women between the ages of 50 and 69. Breast density was classified based on the American College of Radiology's Breast Imaging-Reporting and Data System (BI-RADS). The BI-RADS breast density scale runs from 1 to 4, with 1 being the least dense and 4 being the most dense.

There were 257 malignancies detected on FFDM and a combination of FFDM and tomosynthesis in the study group, including 105 in the density 2 group and 110 in density 3. Of the 257 cancers, 211, or 82 percent were detected with FFDM plus tomosynthesis, a significant improvement over the 163, or 63 percent, detected with FFDM alone.

FFDM plus tomosynthesis pinpointed 80 percent of the 132 cancer cases in women with dense breasts, compared to only 59 percent for FFDM alone.
"Our findings are extremely promising, showing an overall relative increase in the cancer detection rate of about 30 percent," Dr. Skaane said. "Stratifying the results on invasive cancers only, the relative increase in cancer detection was about 40 percent."

Tomosynthesis not only improved the cancer detection rate in women with dense breasts, it also helped increase detection for women in the "fatty breast" BI-RADS categories. The addition of tomosynthesis to FFDM improved the cancer detection rate from 68 percent to 84 percent in women with BI-RADS density 1 or 2 breasts.
"Our results show that implementation of tomosynthesis might indicate a new era in breast cancer screening," Dr. Skaane said.

Top World Best 40 Medical Device Manufacturer

1.  Johnson & Johnson                           

2. General Electric Co.                         

3. Medtronic Inc.                              

4. Siemens AG                                       
7. Koninklijke Philips NV                 
10. Covidien plc                                
13. Boston Scientific Corp.                         
16. St. Jude Medical Inc.                   
19. Zimmer Holdings Inc.                 
22. Toshiba Corp.                               
25. Olympus Corp.                             
28. Varian Medical Systems Inc.        
30. Ship Healthcare Holdings Inc.       
33. Nipro Corp. ⁴                                           
36. Danaher Corp. ⁵                                       
39. MIRACA Holdings Inc.                 

5. Baxter International Inc.                 

6. Fresenius Medical Care AG & Co.

8. Cardinal Health Inc.                       

9. Novartis AG                       

11. Stryker Corp.                                

12. Becton, Dickinson and Co.          

14. Essilor International SA             

15. Allergan Inc.                                 

17. 3M Co.                                          

18. Abbott Laboratories²                                      

20. Terumo Corp.                              

21. Smith & Nephew plc                             

23. CareFusion Corp.                       

24. Getinge AB                                         

26. Bayer AG³                                                

27. CR Bard Inc.                                   

29. DENTSPLY International Inc.   

31. Paul Hartmann AG                          

32. Hologic Inc.                             

34.  Coloplast A/S                            

35. Sonova Holdings                      

37. Edwards Lifesciences                

38. Intuitive Surgical Inc.                  

40. Dragerwerk AG & Co. KGa⁶                 

Medidata and GSK to test mHealth devices for clinical trial optimisation

US-based Medidata has completed a method development project carried out in partnership with GlaxoSmithKline (GSK) to evaluate the impact of unifying mobile health (mHealth) devices with cloud-based technologies in a clinical trial setting.

Conducted at GSK's Human Performance Lab, the joint project evaluated the capabilities of mHealth tools and how they could be used to enable a new model for clinical trial conduct that aligns site and patient needs with faster study execution and reduced costs.

The project showed mHealth technologies can comprehensively collect large volumes of objective data that is reliable, secure and ready for analysis, providing real-time, continuous insight into patients' well being.

Complete data from the project was audited and is said to be compliant with US Food and Drug Administration (FDA) regulations.

"Complete data from the project was audited and is said to be compliant with US Food and Drug Administration (FDA) regulations."

In addition, the project showed mobile devices can support the long-term goal of lessening the burden on patients participating in studies by streamlining routine procedures and reducing visits to clinical trial sites.

Medidata president Glen de Vries said: "Working with GSK on this initiative provided us with an exciting opportunity to show how technology can be used to enhance patient engagement and accelerate the pace of innovation in drug development.

"We gathered data on an unprecedented scale, collecting more than 18 million data points on activity and vital signs per participant per day.

"This is an extraordinary level of in-life, real-time patient instrumentation for clinical trials, which will create new disciplines and new opportunities for life science companies."

In the project, participants were given two wearable devices Vital Connect's HealthPatch MD and ActiGraph's wGT3X-BT Monitor to continuously measure vital signs, electrocardiogram (ECG) data and activity levels.

Additionally, participants used Medidata Patient Cloud, a mobile app for patient-reported outcomes, offered as part of Medidata's technology platform.

Patients carried smartphones that captured data from mHealth devices, which pulled this data into the Medidata Clinical Cloud and then mapped it to the clinical record.

During the trial, patients were asked to continue their standard daily routine and checked in with the performance lab only at the start and end of the effort.

Vital Connect chairman Dr Nersi Nazari said: "Seamlessly integrating data from HealthPatch MD into clinical records through the Medidata Clinical Cloud opens up new possibilities to measure biometrics, from heart rate to skin temperature."