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

NCT02627313 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-11-23

No results posted yet for this study

Summary

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.

Conditions

  • Breast Neoplasms

Interventions

DEVICE

GammaPod Tumour Bed Boost

Single fraction Tumour Bed boost of 8Gy in 1 Fraction

Sponsors & Collaborators

  • Ottawa Hospital Research Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-31
Primary Completion
2021-12-31
Completion
2022-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02627313 on ClinicalTrials.gov