PDT was cleared for use in the US by the FDA, in 2000, under a PMA (Pre-Market Approval) See:
http://www.fda.gov/cdrh/pdf/P990021a.pdf The photosensitizing agent was approved in 2003
See:
http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01246.html "Wizard X-Cell" PDT PMA:
http://www.fda.gov/cdrh/pdf2/P020021b.pdf There has also been one reported death:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=129541 Please notice the indications for use in the above PMA summaries. They are very specific.
The EU has different protocols for allowing devices for "investigational use" so this treatment may not be available in the US for H&N cancers, per se, unless they are "off-label" or clinical trials are in place to prove efficacy for expanding it's indications for use. Vascular use sounds like a great application for this because of it's limited penetration depth and the fact that vascular is typically just below the surface of the skin. In the instance of an H&N tumor, it simply doesn't have enough penetration to insure safe margins, especially if the tumor is larger than 1/3" (about 3mm). Most US doctors want a 1 cm margin around a tumor, minimum.
Remember that most scanning modalities can't detect a tumor smaller than 2mm.
It is cleared for esophogeal application so those tumors must be well within the maximum penetration depth.
They may be able to develop more powerful or application specific lasers and more efficacious drugs to enhance the performance and depth penetration as time goes on.
As noted above, it can have some serious adverse effects, although, IMO, less than ionizing radiation.
This powerpoint was done in 2003 and obviously there is much more information needed:
http://www.fda.gov/ohrms/dockets/ac/03/slides/3966S2_02_FDA-Kaminskas_files/frame.htm#slide0001.htm Here is a Mayo Clinic link to the original studies - PDT has been around for 25 years. It looks particulary interesting for early stage SCC in the lungs.
http://www.mayoclinicproceedings.com/inside.asp?a=1&ref=7207e I am all for everyone being their own patient advocate and my intent is to educate about the current limitations for the device, particularly in the US. It sure sounds promising and I would love to see an additional weapon in the war against H&N cancer.