Treatment of Primary Breast Cancer Using PDT
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|ClinicalTrials.gov Identifier: NCT02872064|
Recruitment Status : Completed
First Posted : August 18, 2016
Last Update Posted : April 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Drug: Verteporfin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/IIa, Open Label, Single Site Light Dose Escalation Trial of Single Dose Verteporfin Photodynamic Therapy (PDT) in Primary Breast Cancer|
|Actual Study Start Date :||January 2013|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||December 2017|
Experimental: Treatment with PDT
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.
Other Name: Visudyne
- Establish the minimum effective light dose [ Time Frame: One month ]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.
- Compare final histology with post PDT MRI. [ Time Frame: One month ]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.
- Assess affect of PDT on normal breast tissue. [ Time Frame: One month ]To look at the effect of Photodynamic Therapy on the abnormal breast tissue and study if necrosis extends to normal breast tissue.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02872064
|Royal Free Hospital|
|London, United Kingdom, NW3 2QG|
|Principal Investigator:||Mo RS Keshtgar||Royal Free NHS Trust|