MedTrace Logo

The Gamma Pod: A Clinical Feasibility Study Device GCC 1202: The Gamma Pod: A Clinical Feasibility Study

NCT02507960 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2022-01-14

Study results available
· View outcomes & findings →

Summary

In this study, investigators plan to deliver a 8 Gy Tumor Bed (TB) boost using the Gamma Pod™ system followed by a conventional (50Gy in 25 fractions) or hypofractionated (40Gy in 15 fractions) course of whole breast radiation. The clinical target volume receiving 8 Gy will be the surgical cavity as defined by the surgical clips and post-surgical changes + 5 mm. The planning target volume (PTV) will add 5 mm to the clinical target volume to account for geometric uncertainties.

Conditions

Interventions

DEVICE

The Gamma Pod

Immobilization of breast during radiation.

DEVICE

CT simulation

See arm description

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Elizabeth M Nichols, MD · University of Maryland, Baltimore

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-06-30
Completion
2018-08-09

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02507960 on ClinicalTrials.gov