Treatment of Primary Breast Cancer Using PDT

NCT ID: NCT02872064

Last Updated: 2018-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2017-12-31

Brief Summary

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.

Conditions

Breast Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Verteporfin

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Visudyne

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mo RS Keshtgar

Role: PRINCIPAL_INVESTIGATOR

Royal Free NHS Trust

Locations

Royal Free Hospital

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

09/0286

Identifier Type: -

Identifier Source: org_study_id