Treatment of Primary Breast Cancer Using PDT

Sponsor
University College, London
Study ID
NCT02872064
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
30 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Verteporfin — DRUG
    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.

Study Details

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

Key Dates

Start date
Jan 31, 2013
Status verified
Mar 2018
Primary completion
Nov 30, 2017
Completion
Dec 31, 2017

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Establish the minimum effective light dose [ Time Frame: One month ]

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