Neoplasms

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Breast Neoplasms

Breast Diseases

Skin Diseases

Single fraction Tumour Bed boost of 8Gy in 1 Fraction

GammaPod Tumour Bed Boost

Conventional breast radiotherapy is delivered to the entirety of the breast in fractionated treatments given over several weeks. While these techniques are effective, there is a risk of late adverse events from irradiation of surrounding normal tissues and the protracted nature of the treatments is inconvenient to patients and resource-intensive for health care systems. There is an unmet need for novel treatments that can be delivered more quickly, with reduced normal tissue exposure, and without compromising efficacy. The GammaPod is a breast-specific radiotherapy delivery device that holds the promise in addressing these needs. Employing the engineering and physics principles from stereotactic radiotherapy, it allows delivery of a highly-localized radiation dose to a very limited volume of breast. The Ottawa Hospital is the only Canadian member of a consortium of five academic institutions that have acquired the GammaPod in order to rigorously evaluate its use in clinical trials. The aim of the current project is to complete a mandatory clinical feasibility study of the GammaPod as part of the application for Investigational Testing of Medical Devices from Health Canada. The study will focus on the use of the GammaPod to deliver a radiotherapy boost, that is, a localized dose of radiation just around the surgical bed, in a single treatment.

Tumor Bed Dose Delivery Using A Breast Specific Radiosurgery Device, The Gammapod: (A Clinical Feasibility Study)

Definition of treatment acceptability

No deviation (acceptable): 100% prescription isodose surface covers at least 95% of the PTV. The near-minimum PTV dose (D98%) must be greater than 7.2 Gy and near-maximum PTV dose (D2%) must be less than 9.6 Gy.

Minor deviation but acceptable: 95% prescription isodose surface covers between 95% and 100% of the PTV. No portion of the PTV receives \<93% of the prescription dose. Near-maximum dose (D2%) to PTV exceeds prescription dose by \>20% but \<30%. All specified critical normal tissue DVH limits fall within 5% of the guidelines.

Major deviations (unacceptable): 95% isodose surface covers \< 95% of the PTV. A portion of PTV receives \< 93% of the prescription dose. Near-maximum dose to PTV exceeds prescription dose by \>30%. Any critical normal tissue DVH limit exceeds 5% of the specified value.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Tumor Bed Dose Delivery Using A Breast Specific Radiosurgery Device, The Gammapod: (A Clinical Feasibility Study)	NCT02627313	Breast Neoplasm...	GammaPod Tumour...	18 Years - 50 Years	Ottawa Hospital Research Institute
Tumor Bed Dose Delivery Using A Breast Specific Radiosurgery Device, The Gammapod: (A Clinical Feasibility Study)	NCT02627313	Breast Neoplasm...	GammaPod Tumour...	18 Years - 50 Years	Ottawa Hospital Research Institute

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