- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02872064
Treatment of Primary Breast Cancer Using PDT
April 4, 2018 updated by: University College, London
A Phase I/IIa, Open Label, Single Site Light Dose Escalation Trial of Single Dose Verteporfin Photodynamic Therapy (PDT) in Primary Breast Cancer
Phase I/IIA, open label, non-randomised, single site trial in patients with primary breast cancer.
Study Overview
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
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, NW3 2QG
- Royal Free Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Establish the minimum effective light dose
Time Frame: One month
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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.
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One month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare final histology with post PDT MRI.
Time Frame: One month
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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.
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One month
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Assess affect of PDT on normal breast tissue.
Time Frame: One month
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To look at the effect of Photodynamic Therapy on the abnormal breast tissue and study if necrosis extends to normal breast tissue.
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One month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mo RS Keshtgar, Royal Free NHS Trust
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2013
Primary Completion (Actual)
November 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
August 15, 2016
First Submitted That Met QC Criteria
August 17, 2016
First Posted (Estimate)
August 18, 2016
Study Record Updates
Last Update Posted (Actual)
April 6, 2018
Last Update Submitted That Met QC Criteria
April 4, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09/0286
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD 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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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