IMDS - CTML - Value without contrast agents?

Implications: The recent upgrade of the Computed Tomography Laser Mammography (CTLM(R)) system will only added minor details. The question whether this system without any contrast agent is of any value has not been answered so far.

Analysis: The recent upgrade of the Computed Tomography Laser Mammography (CTLM(R)) system will only added minor details. The question whether this system without any contrast agent is of any value has not been answered so far. The system so far relies on hemoglobin density and the assumption that malignant breast tumors have a dense net of vessels and therefore a higher hemoglobin concentration in the surrounding area. This may be true for large tumors but not necessarily for small tumors. In addition because of the non-linear movement a photon is performing spatial resolution is critical so far and achievable contrast levels are not high enough. It can not be seen how these problems are solved by the update.
There are more sites outside the US than within the US that do research with the CTML. Therefore the question whether this system should be allowed to for investigational purposes outside the US was answered 5 years ago and the answer was "yes", partially because the system was not approved in the US and the FDA too restrictive!