Treatment of Primary Breast Cancer Using PDT

NCT02872064 | Completed DMC

• 1 other identifier: 09/0286
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Neoplasms

Keywords

Early breast cancer; Photodynamic therapy; PDT; Visudyne; Verteporfin

Outcome Measures

Primary Outcomes (1)

• Establish the minimum effective light dose

  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.

  One month

Secondary Outcomes (2)

• Compare final histology with post PDT MRI.

  One month

• Assess affect of PDT on normal breast tissue.

  One month

Study Arms (1)

Treatment with PDT

EXPERIMENTAL

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.

Drug: Verteporfin

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.

Also known as: Visudyne

Treatment with PDT

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 30 or over
• A uni-focal invasive ductal breast carcinoma or discrete uni-focal site which is deemed suitable for PDT within a multifocal invasive ductal carcinoma in a single breast.
• Patients who have opted for mastectomy or wide local excision as primary treatment.
• Capable of giving written informed consent

You may not qualify if:

• Patients who are not undergoing surgery as their primary treatment.
• Patients undergoing surgery for DCIS without invasive breast cancer.
• Patients with Lobular cancer
• Patients with Necrotic tumours
• Distant metastatic disease.
• Patients will be excluded if they have porphyria or are sensitive to verteporfin (visudyne).
• Patients who have severe cardiovascular disease.
• Patients with severe or uncontrolled systemic disease e.g. hepatic impairment.
• Patients with laboratory findings that make it undesirable for the patient to participate in the trial.
• Male breast cancer patients
• Pregnancy and lactation.
• No patients with any psychiatric disorder making reliable informed consent impossible.
• Patients will be excluded if taking part in any other trial of an experimental medicine
• Patients will be excluded if taking endocrine therapy drugs that could confound the results.

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Verteporfin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Mo RS Keshtgar

  Royal Free NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: August 18, 2016
• Study Start: January 1, 2013
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 6, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)