Breast NeoplasmsNCT02872064
Treatment of Primary Breast Cancer Using PDT
A study testing Verteporfin in people with Breast Neoplasms, run by University College, London at 1 site in United Kingdom.
Trial summary
Phase I/IIA, open label, non-randomised, single site trial in patients with primary breast cancer. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Verteporfin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Phase I/IIA, open label, non-randomised, single site trial in patients with primary breast cancer.
Read the 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.
- Conditions
- Breast Neoplasms
- Being tested
- Verteporfin
- Keywords
- Early breast cancer, Photodynamic therapy, PDT, Visudyne, Verteporfin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VerteporfinDrug
Also called Visudyne
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Verteporfin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One month
Secondary outcomes (2)
Compare final histology with post PDT MRI.
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.
Measured: One month
Assess affect of PDT on normal breast tissue.
To look at the effect of Photodynamic Therapy on the abnormal breast tissue and study if necrosis extends to normal breast tissue.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startJan 2013
- Primary completionNov 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mo RS Keshtgar, Principal investigator, Royal Free NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872064
- Sponsor's protocol ID
- 09/0286
- Status last verified
- Mar 2018
- First submitted
- 15 Aug 2016
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02872064
- Acronym / sponsor ID
- 09/0286
- Conditions
- Breast Neoplasms
- Keywords
- Early breast cancer, Photodynamic therapy, PDT, Visudyne, Verteporfin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 18 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I/IIA, open label, non-randomised, single site trial in patients with primary breast cancer.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with PDT | Experimental | Drug: VerteporfinA 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VerteporfinAlso: VisudyneVerteporfin (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. | Drug | Treatment with PDT |
Primary outcome
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.
2 secondary outcomes
Compare final histology with post PDT MRI.
Time frame: One month
Assess affect of PDT on normal breast tissue.
Time frame: One month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mo RS Keshtgar principal investigator
Royal Free NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verteporfin in people with Breast Neoplasms, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish the minimum effective light dose (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.