Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Neoplastic Processes

Dermatologic Agents

All Drugs and Chemicals

Verteporfin

Photosensitizing Agents

Visudyne

An estimated 10 percent of primary breast, prostate, lung, thyroid and renal cell tumors metastasize to the spine. The majority of these tumors are detected before surgical intervention is required and most patients receive radiation therapy for symptomatic relief. Complete pain control, duration of pain control, high recurrence rates and soft tissue complications make radiation a less than ideal treatment. Also, pre-operative radiation therapy is a significant negative predictor for surgical outcomes. To improve the treatment options for patients with advanced cancer with spinal lesions the research team investigated a new minimally invasive therapy known as photodynamic therapy (PDT) that targets metastatic spine lesions with limited side effects. PDT involves the use of a photo-activated chemotherapeutic agent, given intravenously that when stimulated by non-thermal wavelength-specific light allows for selective ablation of tumor tissue. The light is delivered to the spine through small fiber optic cables using a diode laser. By combining canine and porcine studies the investigators have strong evidence to support that PDT is both safe and effective for the treatment of metastatic tumors in the spine. PDT is targeted, repeatable, minimally invasive and has limited local and systemic side effects. Its use would enhance the treatment options for patients with advanced stage cancer. The goal of the present study is to demonstrate that PDT can be safely and effectively given to treat spinal metastases in patients with advanced stage cancer who have multiple lesions or who have failed radiation or surgical intervention. The effectiveness of this treatment will be determined through clinical and radiographic endpoints along with recurrence and survival. The investigators intend to demonstrate that PDT is a minimally invasive method with low morbidity and mortality by which spinal tumors can be ablated and later stabilized through vertebroplasty, optimizing quality of life and providing effective treatment.

There are over 1.5 million cases of cancer reported each year in North America and a significant number of patients eventually suffer from metastases to the spine which present as an extremely challenging problem for both the clinician and patient. Primary tumors that most commonly affect the spine include breast, prostate, lung, thyroid and renal cell cancer. Estimates from large clinical series report at least a 10 percent rate of metastases to the spine from these most common tumors. These lesions are extremely painful and significantly affect the quality of life of advanced stage cancer patients. The majority of these tumors are detected before surgical intervention is required and most patients receive radiation therapy for their spine lesions for symptomatic relief. However, complete pain control, duration of pain control along with a high recurrence rate of lesions and soft tissue complications makes radiation a less than an ideal treatment. In addition, pre-operative radiation therapy is a significant negative prognosticator for surgical outcomes.

To improve the treatment options for patients with advanced cancer with spinal lesions the research team has investigated a new minimally invasive therapy, known as photodynamic therapy (PDT) that targets metastatic spine lesions directly and has limited side effects. PDT involves the use of a photo-activated chemotherapeutic agent, benzoporphyrin derivative (verteporfin/Visudyne) given intravenously that when stimulated by non-thermal wavelength-specific light allows for selective ablation of tumor tissue. The light is delivered to the spine through small fiber optic cables (outer diameter 0.98mm, inner core of 0.5mm mm) using a diode laser. Visudyne is an FDA and Health Canada approved photosensitizer that has been used in over one million patients for the treatment of age related macular degeneration, a leading cause of blindness in the elderly. To investigate the use of PDT for spinal metastases the investigators initially developed a bioluminescent metastatic rodent model using human breast cancer that metastasized to the spine. Using this model it was determined that PDT was effective at treating metastatic breast cancer lesions in the spine. The research team next utilized non-tumor bearing canine and porcine models to determine that the treatment could be safely delivered to the spine and conduct light dosimetry analysis. The safety of PDT intra-operatively was assessed using somatosensory evoked potentials and through post-treatment clinical examination and magnetic resonance imaging (MRI). The effects PDT had on the spine were analyzed by comparing pre-operative and post-operative MR imaging and correlating those in turn with histological analysis. None of these animals suffered weakness or complication from the use of PDT around the spinal cord. During these studies the investigators developed the planning, delivery and instrumentation methodologies to deliver PDT to spinal tumors and the methodology to combine this therapy with vertebroplasty, a percutaneous method of stabilizing the spine. In addition, in a separate set of studies, highgrade osteosarcomas in canines were treated to determine the effect PDT had on large bone tumors. The results of this study again provided comparison of pre and post-treatment effects seen on MRI and histological analysis. The volume of effect seen in the osteosarcomas was up to 25cm (cubed) and was comparable to the volume of effect required for complete treatment of spinal lesions. By combining the canine and porcine studies there is strong evidence that PDT is both safe and effective for the treatment of metastatic tumors in the spine.

PDT has many advantages over current therapies; it is targeted, repeatable, minimally invasive and has limited local and systemic side effects. Its use would enhance the treatment options for patients with advanced stage cancer. The goal of the present study is to demonstrate that PDT can be safely and effectively given to treat spinal metastases in patients with advanced stage cancer. The study is a pilot study and will determine the safe and accurate treatment of 30 patients with spinal metastases who have multiple lesions or who have failed radiation or surgical intervention. The effectiveness of this treatment will be determined through clinical and radiographic endpoints with recurrence and survival also determined. The investigators intend to demonstrate that PDT provides a minimally invasive method with low morbidity and mortality by which spinal tumors can be ablated and later stabilized through vertebroplasty, optimizing quality of life and providing effective treatment for this devastating manifestation of advanced stage cancer.

Photodynamic Therapy for the Treatment of Vertebral Metastases

Photodynamic Therapy (PDT) for the Treatment of Vertebral Metastases: A Prospective Phase I Clinical Trial

The analgesic effect of surgical treatment will be estimated using the SF-36

The analgesic effect of surgical treatment will be estimated using the visual analogue (VAS) pain scale.

Intraoperative dosimetry data on light transmission and attenuation in patient specific diseased bone will be contrasted to pre-operative imaging data and the region of effect based on actual light transmission compared to pre-operative planning algorithms. These results will gauge the potential accuracy of our planning algorithms.

The primary safety parameter will be unexpected worsening in neurological function.

Physical examination will include a detailed neurological examination (including ASIA score) that assesses the strength, sensation and reflexes of the patient in the upper and lower extremities

Sunnybrook Health Sciences Centre

Orthopaedic Surgeon

Eye Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Retinoblastoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Retinal Neoplasms

Eye Neoplasms

Eye Diseases, Hereditary

Retinal Diseases

Neuroepithelioma

Central Nervous System Depressants

Gastrointestinal Agents

Anesthetics

Lactitol

All the patients received once PDT with Visudyne® as the initial treatment. Rescue treatment with systemic chemotherapy would be given to patients if tumors were insensitive to PDT treatment, the tumors became larger, or disease relapse.

PDT with Visudyne® was performed under general anesthesia according to the standard TAP study with some modifications: Verteporfin (6 mg/m2, Visudyne®; Novartis International AG, Basel, Switzerland) was injected intravenously with a standard 10-min infusion followed by followed by application of diode laser (Opal Photoactivator; Coherent Medical Group, Santa Clara, USA) (689 nm, 50 J/cm2, 600 mW/cm2) for 200 seconds to generate 120 J/cm2.

photodynamic therapy

To study the effectiveness and safety profiles of photodynamic therapy (PDT) for the treatment of human retinoblastoma.

Retinoblastoma is the commonest primary intraocular malignancy in infancy and early childhood. Ophthalmologist are trying to seek other more safe and effective treatment modalities to well control the tumor and preserve the visual function. Photodynamic therapy (PDT) is a potentially therapeutic approach for retinoblastoma which has been underestimated. In this study, we are gonging to investigate the the effectiveness and safety profiles of photodynamic therapy (PDT) for the treatment of human retinoblastoma.

Photodynamic Therapy With Visudyne for Human Retinoblastoma: A Preliminary Study

the rate of eye enucleation of patients with retinoblastoma in different groups

Sun Yat-sen University

Prof.

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

A single intravenous injection of Verteporfin (0.4mg/kg) will be administered, at least 60minutes and up to 90 minutes before laser activation. A 690nm red laser light will be delivered with a diffuser laser fibre inserted through the skin into the breast tissue, with light dose escalation after every three patients. All patients will have fixed dose of the photosensitizer but variable light dose.

Verteporfin (which is marketed under the brand name Visudyne) is the photosensitizer. Verteporfin is a benzoporphyrin derivative which is clinically active when formulated with liposomes. By itself the clinically recommended dose of Verteporfin is not cytotoxic. It produces cytotoxic agents only when activated by light in the presence of oxygen. When energy absorbed by the porphyrin is transferred to oxygen, highly reactive short lived singlet oxygen is generated. Singlet oxygen causes damage to biological structures, leading to local vascular occlusion, cell damage and cell death.

Mo RS Keshtgar

Phase I/IIA, open label, non-randomised, single site trial in patients with primary breast cancer.

This is a phase I / IIa study recruiting patients diagnosed with primary breast cancer. Patients who have chosen mastectomy or wide local excision as their surgical option will be included. Patients will have a pre therapy MRI followed by photodynamic therapy. PDT involves intravenously injecting the photosensitizer Verteporfin (Visudyne) drug. This drug makes the tumour sensitive to light. A non-thermal light will then be shone in the tumour which brings about tissue necrosis (destruction). Although the drug dose will remain the same, the light dose will be escalated depending on patient response in accordance to a predefined algorithm (see section) to achieve a zone of necrosis of 12mm or a plateau of necrosis with incremental increase in light dose. An MRI will be performed immediately prior to the scheduled surgery. Pre and post PDT MRI changes will be correlated with the histological findings on the excised breast specimen. Should the minimum light dose for 12mm necrosis be established recruitment will continue until 12 patients have received this dose. These 12 patients will provide sample data on the size of tumour and area of necrosis detected by MRI and histology to enable sample size (power) calculations for future studies of PDT in primary breast cancer. This is a dose escalation study involving a minimum of twelve and a maximum of forty patients.

Treatment of Primary Breast Cancer Using PDT

A Phase I/IIa, Open Label, Single Site Light Dose Escalation Trial of Single Dose Verteporfin Photodynamic Therapy (PDT) in Primary Breast Cancer

All requests for data sharing will adhere to the UCL Surgical \& Interventional Trials Unit (SITU) data sharing agreement policy. UCL Medical School is supportive of data sharing and will endeavour to assist in requests for data sharing. These data will be held at UCL on secure servers and will not be released to any third parties until the final study report has been published. All requests for access to the data will be formally requested through the use of a SITU data request form which will state the purpose, analysis and publication plans together with the named collaborators. All requests are dealt with on a case by case basis. All requests will be logged and those successful will have a data transfer agreement which will specify appropriate acknowledgement of the Royal Free Hospital, the sponsor, and funders.

To establish the minimum light dose, in the range 20Joules/ (cm of light diffuser length) but not exceeding 90J/cm, required to induce an area of necrosis with a diameter of at least 12mm in line perpendicular to the fibre on microscopic examination or to achieve a plateau with no increasing necrosis as the light dose increases.

To assess the response of the Photodynamic Therapy on primary breast cancer via radiology using pre and post PDT MRI and comparing this with final histology. Measurements will be made of the diameter of necrosis on MRI scan which will be correlated with the histological measurement.

To look at the effect of Photodynamic Therapy on the abnormal breast tissue and study if necrosis extends to normal breast tissue.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Photodynamic Therapy for the Treatment of Vertebral Metastases	NCT02464761	Vertebral Metas...	Visudyne	20 Years - 85 Years	Sunnybrook Health Sciences Centre
Photodynamic Therapy With Visudyne for Human Retinoblastoma: A Preliminary Study	NCT04429139	Retinoblastoma	photodynamic th...	1 Year - 20 Years	Sun Yat-sen University
Photodynamic Therapy With Visudyne for Human Retinoblastoma: A Preliminary Study	NCT04429139	Retinoblastoma	photodynamic th...	1 Year - 20 Years	Sun Yat-sen University
Treatment of Primary Breast Cancer Using PDT	NCT02872064	Breast Neoplasm...	Verteporfin	30 Years -	University College, London
Photodynamic Therapy With Visudyne for Human Retinoblastoma: A Preliminary Study	NCT04429139	Retinoblastoma	photodynamic th...	1 Year - 20 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for visudyne

Every month we try and update this database with for visudyne cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for visudyne

Every month we try and update this database with for visudyne cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for visudyne cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.