DIBH Proton Planning

NCT01386697 | Completed DMC

• 1 other identifier: UPCC 13910
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective is to estimate the actual or potential benefit of deep inspiration breath holding (DIBH) treatment in the context of proton radiotherapy as compared to 3 dimensional conformal radiation therapy (3DCRT) and intensity-modulated x-ray therapy (IMXT), as it relates to variability in tumor localization, treatment margins, target volume definition, doses to organs at risk and variations with treatment planning.

Conditions

Lung Cancer; Breast Cancer; Gastrointestinal; Lymphomatous Malignancies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This registry study will enroll patients who are 18 years of age or older who select to undergo external beam radiation therapy as definitive or adjuvant treatment for their diagnosis of lung, breast, gastropintestinal or lymphomatous malignancies in the Department of Radiation Oncology.

You may qualify if:

• Age 18 and older
• Biopsy-proven malignancy
• The diagnosis of hepatocellular carcinoma may be made on a clinical basis without the need for a biopsy if the following criteria are met: a) Documentation of hepatitis B or C infection b)Liver mass with characteristic imaging (CT or MRI) features of hepatocellular carcinoma c) Alpha-feta protein (AFP) level greater than 20 ng/mL 3. Planned curative external beam RT as part of the patients treatment for the cancer diagnosis.
• Subject must be cable of giving informed consent for standard external beam radiation therapy as well as for the study.
• Subjects must be able to tolerate the deep inspiration breath hold (DIBH) training and procedures.

You may not qualify if:

• Subjects unsuitable for or unable to undergo definitive external beam, radiation therapy for their diagnosis of cancer
• Subjects undergoing radiation with palliative (i.e., non-curative) intent.
• Subjects unwilling to undergo simulation with the SpiroDynrX (SDX) system.
• Subjects unable to hold their breath for a minimum of 10 seconds.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• John Plastaras, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2011
• First Posted: July 1, 2011
• Study Start: November 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

US (1)