ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment of Primary Breast Cancer Using PDT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02872064
Recruitment Status : Completed
First Posted : August 18, 2016
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
University College, London

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

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Verteporfin Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Verteporfin
U.S. FDA Resources

Arm Intervention/treatment
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.
Drug: Verteporfin
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients aged 30 or over
  2. 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.
  3. Patients who have opted for mastectomy or wide local excision as primary treatment.
  4. Capable of giving written informed consent

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Locations
United Kingdom
Royal Free Hospital
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
University College, London
Investigators
Principal Investigator: Mo RS Keshtgar Royal Free NHS Trust

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02872064     History of Changes
Other Study ID Numbers: 09/0286
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

Keywords provided by University College, London:
Early breast cancer
Photodynamic therapy
PDT
Visudyne
Verteporfin

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Verteporfin
Photosensitizing Agents
Dermatologic Agents