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

NCT02507960 | Completed Results DMC

• 1 other identifier: HP-00052062
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 4

Brief 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

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Demonstration of the Feasibility and Safety of Delivering a Radiation Treatment Using the GammaPod (TM)

  Patients must be undergoing breast conserving therapy and PI will evaluate for feasibility by ensuring coverage of the target volume with appropriate dose homogeneity and conformity as defined in the study. Per inclusion criteria, the volume of the tumor bed clinical target volume (CTV) is less than 25% of the whole breast planning target volume (PTV) which is a criteria used for partial breast alone trials (ie. NSABP B-39). If the tumor bed cannot fit this criteria, then patient is unable to be treated utilizing GammaPod.

  1 year

Secondary Outcomes (3)

• Number of Participants With Acute Toxicities Measured by Common Terminology Criteria for Adverse Events (CTCAE); The Evaluation of Acute Toxicity During and up to 1 Month After Gamma Pod TB Boost.

  2 months

• Number of Participants With Long-term Toxicities Measured by Common Terminology Criteria for Adverse Events (CTCAE); The Evaluation of Long-term Toxicity at One Year to Assess the Presence of Subcutaneous Fibrosis and Fat Necrosis.

  1 year

• Efficacy of Medical Adhesive; Number of Participants With Adverse Events From the Use of the Adhesive Spray

  1 year

Study Arms (1)

Pilot Study

OTHER

The patient will undergo a conventional CT simulation in supine position without the breast immobilization cup. The purpose of the CT simulation is-two-fold: 1) the investigators will see if the TB volume can be accurately delineated and if the TB volume is too large for Gamma Pod boost; and 2) the CT images are used for planning the patient's whole breast irradiation. If, after viewing the CT images and the patient is deemed a study candidate and consents, the participants will receive a second CT-sim and the Gamma Pod TB boost treatment on the same day as described below.

Device: The Gamma Pod; Device: CT simulation

Interventions

The Gamma Pod DEVICE

Immobilization of breast during radiation.

Pilot Study

CT simulation DEVICE

See arm description

Pilot Study

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must sign consent for study participation.
• The patient must be female and have a diagnosis of an invasive or non-invasive breast cancer that was treated surgically by a partial mastectomy.
• The patient must be deemed an appropriate candidate for breast conserving therapy (i.e. not pregnant, never had radiation to the treated breast, breast size would allow adequate cosmesis after volume loss from partial mastectomy).
• Patients with involved lymph nodes are candidates for the study as long as regional nodal radiation is not required by the treating physician.
• Surgical margins are negative for invasive or non-invasive breast cancer.
• The greatest dimension of the tumor is less than 4cm before surgery.
• The volume of the TB CTV is less than 25% of the whole breast PTV which is a criteria used for partial breast alone trials (NSABP B-39).
• Multifocal disease is allowed if it was removed by a single lumpectomy resection and the patient remained a candidate for breast conservation.
• Age 60 years and older.
• Women of childbearing potential must use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills.A negative pregnancy test must be obtained prior to study enrollment or waiver signed.
• The surgical cavity is clearly visible on CT images.
• The patient must weigh less than 150Kg (330lb), which is the limit of the imaging couch.
• The patient must feel comfortable in the prone position.

You may not qualify if:

• Patients with proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm).
• Prior radiation therapy above the umbilicus
• Unable to fit into the immobilization breast cup with an adequate seal
• Male gender.
• Patient cannot comfortably be set up in the prone position (i.e. physical disability)
• Unable to fit into the breast immobilization device due to breast size or other anatomical reason.
• Mastectomy is the surgery performed.
• Patient has received prior radiotherapy to the involved breast.
• Regional nodal irradiation is part of the treatment plan.
• Tumor bed is less than 5 mm from the skin surface.
• Patients with skin involvement, regardless of tumor size.
• Patients with connective tissue disorders specifically systemic lupus erythematosis, scleroderma, or dermatomyositis.
• Patients with psychiatric or addictive disorders that would preclude obtaining informed consent.
• Patients who are pregnant or lactating due to potential exposure of the fetus to RT and unknown effects of RT to lactating females.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (4)

Ummc Msgccc

Baltimore, Maryland, 21201, United States

Location

Upper Chesapeake Health

Bel Air, Maryland, 21014, United States

Location

Central Maryland Oncology Center

Columbia, Maryland, 21044, United States

Location

Baltimore Washington Medical Center

Glen Burnie, Maryland, 21061, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Elizabeth Nichols
• Organization: University of Maryland Medical Center

enichols1@umm.edu

4103287586

Study Officials

• Elizabeth M Nichols, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 16, 2015
• First Posted: July 24, 2015
• Study Start: January 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: August 9, 2018
• Last Updated: January 14, 2022
• Results First Posted: January 14, 2022

Record last verified: 2022-01

Locations

US (4)