Techniques for delivery and monitoring of TOOKAD (WST09)-mediated photodynamic therapy of the prostate: clinical experience and practicalities.

Photodynamic therapy of solid organs requires sufficient PDT dose throughout the target tissue while minimizing the dose to proximal normal structures. This requires treatment planning for position and power of the multiple delivery channels, complemented by on-line monitoring during treatment of light delivery, drug concentration and oxygen levels. We describe our experience in implementing this approach in Phase I/II clinical trials of the Pd-bacteriophephorbide photosensitizer TOOKAD (WST09)-mediated PDT of recurrent prostate cancer following radiation failure. We present several techniques for delivery and monitoring of photodynamic therapy, including beam splitters for light delivery to multiple delivery fibers, multi-channel light dosimetry devices for monitoring the fluence rate in the prostate and surrounding organs, methods of measuring the tissue optical properties in situ, and optical spectroscopy for monitoring drug pharmacokinetics of TOOKAD in whole blood samples and in situ in the prostate. Since TOOKAD is a vascular-targeted agent, the design and implementation of the techniques are different than for cellular-targeted agents. Further development of these delivery and monitoring techniques will permit full on-line monitoring of the treatment that will enable real-time, patient-specific and optimized delivery of PDT.

[1]  Masoud Panjehpour,et al.  Photodynamic therapy for Barrett's esophagus with dysplasia and/or early stage carcinoma: long-term results. , 2003, Gastrointestinal endoscopy.

[2]  W Verkruysse,et al.  Modelling light distributions of homogeneous versus discrete absorbers in light irradiated turbid media. , 1997, Physics in medicine and biology.

[3]  H. J. van Staveren,et al.  Light scattering in Intralipid-10% in the wavelength range of 400-1100 nm. , 1991, Applied optics.

[4]  W. Star,et al.  Performance of isotropic light dosimetry probes based on scattering bulbs in turbid media. , 2002, Physics in medicine and biology.

[5]  B. Wilson,et al.  Comparison of the In Vivo Photodynamic Threshold Dose for Photofrin, Mono‐ and Tetrasulfonated Aluminum Phthalocyanine Using a Rat Liver Model , 1998, Photochemistry and photobiology.

[6]  H. Kato,et al.  Photodynamic therapy for peripheral lung cancer. , 2004, Lung cancer.

[7]  Lothar Lilge,et al.  Optical characteristics of the canine prostate at 665 nm sensitized with tin etiopurpurin dichloride: need for real-time monitoring of photodynamic therapy. , 2004, The Journal of urology.

[8]  N. Bressler,et al.  Natural history of minimally classic subfoveal choroidal neovascular lesions in the treatment of age-related macular degeneration with photodynamic therapy (TAP) investigation: outcomes potentially relevant to management--TAP report No. 6. , 2004, Archives of ophthalmology.

[9]  Edna Furman-Haran,et al.  Parametric analysis of breast MRI. , 2002, Journal of computer assisted tomography.

[10]  Alon Harmelin,et al.  Local photodynamic therapy (PDT) of rat C6 glioma xenografts with Pd‐bacteriopheophorbide leads to decreased metastases and increase of animal cure compared with surgery , 2002, International journal of cancer.

[11]  M. Mycek,et al.  Handbook of Biomedical Fluorescence , 2003 .

[12]  S. Hahn,et al.  Interstitial photodynamic therapy for prostate cancer: a developing modality. , 2004, Photodiagnosis and photodynamic therapy.

[13]  Hadassa Degani,et al.  Parametric imaging of tumor perfusion using flow‐ and permeability‐limited tracers , 2002, Journal of magnetic resonance imaging : JMRI.

[14]  M S Patterson,et al.  The use of India ink as an optical absorber in tissue-simulating phantoms , 1992, Physics in medicine and biology.

[15]  Brian C. Wilson,et al.  Treatment planning platform for photodynamic therapy: architecture, function, and validation , 2002, SPIE BiOS.

[16]  Henricus J C M Sterenborg,et al.  In situ light dosimetry during photodynamic therapy of Barrett's esophagus with 5‐aminolevulinic acid , 2002, Lasers in surgery and medicine.

[17]  M S Patterson,et al.  Experimental verification of the effect of refractive index mismatch on the light fluence in a turbid medium. , 1999, Journal of biomedical optics.

[18]  M R Arnfield,et al.  OPTICAL PROPERTIES OF EXPERIMENTAL PROSTATE TUMORS in vivo , 1993, Photochemistry and photobiology.

[19]  A. Lucky,et al.  Photodynamic therapy with topical methyl aminolevulinate for actinic keratosis: results of a prospective randomized multicenter trial. , 2003, Journal of the American Academy of Dermatology.

[20]  Victor X. D. Yang,et al.  High-sensitivity detection and monitoring of microcirculation using cutaneous and catheter probes for Doppler optical coherence tomography , 2003, SPIE BiOS.

[21]  Michal Neeman,et al.  Antivascular Treatment of Solid Melanoma Tumors with Bacteriochlorophyll–serine-based Photodynamic Therapy¶ , 2001 .

[22]  Mamoru Tamura,et al.  Expression of optical diffusion coefficient in high-absorption turbid media , 1997 .

[23]  Georg Bartsch,et al.  Photodynamic therapy with intravesical instillation of 5-aminolevulinic acid for patients with recurrent superficial bladder cancer: a single-center study. , 2003, Urology.

[24]  L. Kou,et al.  Refractive indices of water and ice in the 0.65- to 2.5-µm spectral range. , 1993, Applied optics.

[25]  M S Patterson,et al.  In vivo TESTS OF THE CONCEPT OF PHOTODYNAMIC THRESHOLD DOSE IN NORMAL RAT LIVER PHOTOSENSITIZED BY ALUMINUM CHLOROSULPHONATED PHTHALOCYANINE , 1990, Photochemistry and photobiology.

[26]  W. Star,et al.  Calibration of isotropic light dosimetry probes based on scattering bulbs in clear media. , 1996, Physics in medicine and biology.

[27]  Zheng Huang,et al.  Preclinical Studies in Normal Canine Prostate of a Novel Palladium-Bacteriopheophorbide (WST09) Photosensitizer for Photodynamic Therapy of Prostate Cancer¶ , 2002, Photochemistry and photobiology.

[28]  S. Jacques,et al.  Light Distributions from Point, Line and Plane Sources for Photochemical Reactions and Fluorescence in Turbid Biological Tissues , 1998, Photochemistry and photobiology.

[29]  Michal Neeman,et al.  Monitoring photodynamic therapy of solid tumors online by BOLD-contrast MRI , 2003, Nature Medicine.

[30]  A. Radu,et al.  Selectivity of the photosensitiser Tookad® for photodynamic therapy evaluated in the Syrian golden hamster cheek pouch tumour model , 2003, British Journal of Cancer.

[31]  B. Wilson,et al.  Changes in in vivo optical properties and light distributions in normal canine prostate during photodynamic therapy. , 1997, Radiation research.

[32]  Timothy C Zhu,et al.  In vivo Optical Properties of Normal Canine Prostate at 732 nm Using Motexafin Lutetium–mediated Photodynamic Therapy¶ , 2003, Photochemistry and photobiology.

[33]  J. Trachtenberg,et al.  Interstitial microwave thermal therapy for prostate cancer: method of treatment and results of a phase I/II trial. , 2001, The Journal of urology.

[34]  Avigdor Scherz,et al.  Photodynamic therapy with Pd‐bacteriopheophorbide (TOOKAD): Successful in vivo treatment of human prostatic small cell carcinoma xenografts , 2003, International journal of cancer.

[35]  L. Lilge,et al.  Implicit and explicit dosimetry in photodynamic therapy: a New paradigm , 1997, Lasers in Medical Science.

[36]  K. Moghissi,et al.  Photodynamic Therapy (PDT) in Esophageal Cancer: A Surgical View of its Indications Based on 14 Years Experience , 2003, Technology in cancer research & treatment.

[37]  P. Levendag,et al.  Clinical results of photodynamic therapy for superficial skin malignancies or actinic keratosis using topical 5-aminolaevulinic acid , 1996, Lasers in Medical Science.

[38]  H Stepp,et al.  Clinical experience with 5-aminolevulinic acid and photodynamic therapy for refractory superficial bladder cancer. , 2001, The Journal of urology.

[39]  H. Barr,et al.  Photodynamic therapy in the treatment of lung and oesophageal cancers. , 2002, Clinical oncology (Royal College of Radiologists (Great Britain)).

[40]  Robert A Weersink,et al.  Assessment of Cutaneous Photosensitivity of TOOKAD (WST09) in Preclinical Animal Models and in Patients¶ , 2005, Photochemistry and photobiology.

[41]  K. Moghissi.  Role of bronchoscopic photodynamic therapy in lung cancer management , 2004, Current opinion in pulmonary medicine.

[42]  A. Radu,et al.  Evaluation of the Photosensitizer Tookad® for Photodynamic Therapy on the Syrian Golden Hamster Cheek Pouch Model: Light Dose, Drug Dose and Drug–light Interval Effects¶ , 2003, Photochemistry and photobiology.

[43]  W. Star,et al.  In situ light dosimetry during whole bladder wall photodynamic therapy: clinical results and experimental verification. , 1993, Physics in medicine and biology.

[44]  Brian C. Wilson,et al.  Determination of the peak absorption wavelength and disaggregation kinetics of TOOKAD in vivo using dynamic, spatially resolved diffuse reflectance spectroscopy in a rabbit model , 2002, SPIE BiOS.