DIBH Proton Planning

March 9, 2020 updated by: Abramson Cancer Center of the University of Pennsylvania

A Prospective Radiation Oncology Planning Study For Lung, Gastrointestinal And Lymphomatous Malignancies Using Proton Radiotherapy As Compared To 3D Conformal And Intensity-Modulated X-Ray Therapy For Dosimetric Evaluation Of Tumoral Coverage And Dose To Organs-At-Risk.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Image acquisition and treatment under deep inspiration breath hold (DIBH) has been demonstrated to reduce treated volumes and doses to organs at risk (OARs) for photon radiotherapy but has not been investigated in the context of proton radiotherapy. The objective of this registry study is to prospectively evaluate deep inspiration breath hold CT scans for use in proton radiotherapy treatment planning and obtain dosimetric data to assess for changes in target volume, planning volumes and doses both to tumor and organs at risk using the SpiroDynrX (SDX) deep inspiration breath hold system as compared to free breathing and 4D CT scans. Patients will be treated with photon therapy. This is a prospective non-randomized, single arm, single institution registry study of patients undergoing definitive external beam photon radiotherapy in our department. Deep inspiration breath hold CT scans will be obtained in our department in the treatment position at the time of CT simulationin addition to the currently obtained free breathing and 4D CT scans. These scans will all be co-registered with the treatment planning CT. Treatment planning volumes will be delineated by the physician and compared to the results and data for our current standard of care utilizing 4D CT scans. Patients will be treated with breath hold CT using photon radiotherapy but we will prospectively create proton treatment plans which will also be compared to the photon treatment plans used for actual treatment. Variability in tumor localization, target volume definition, doses to organs at risk and treatment planning particularities will be summarized and reported across several modalities, including: 3 dimensional conformal radiation therapy (3DCRT), intensity-modulated x-ray therapy (IMXT) and proton therapy. Correlations will be statistically analyzed and reported in terms of minimum, maximum, average and standard deviation, and other dose volume histogram parameters, and where appropriate, compared with appropriate statistical methods (for example, student t-test).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abramson Cancer Center of the University of Pennsylvania

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John Plastaras, MD, Abramson Cancer Center of the University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UPCC 13910

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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