We have initiated a clinical trial to test the hypothesis that we hypothesize that PDT with the photosensitizing pro-drug ALA and vitamin D3 can be applied to treat anal (pre)malignancy with acceptable toxicity and light dose delivery (NCT02698293) . Here, we report on the design of the trial, a custom apparatus to deliver light while measuring PpIX fluorescence and tissue optical properties, validation of apparatus and initial toxicity in the first treated patients.
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