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DMH-Based Plan Evaluation and Inverse Optimization in Radiotherapy

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ClinicalTrials.gov Identifier: NCT02663817
Recruitment Status : Recruiting
First Posted : January 26, 2016
Last Update Posted : February 7, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ivaylo Mihaylov, University of Miami

Brief Summary:

The hypotheses of the study are as follows:

  • Mass-based inverse optimization in radiotherapy treatment planning will result in a reduction of normal tissue and organs at risk (OAR) doses for desired prescription therapeutic doses to the targets.
  • Dose-mass histograms (DMHs) may be more relevant to radiotherapy treatment planning and treatment plan assessment than the standard of care, realized through dose-volume histograms (DVHs)

Condition or disease Intervention/treatment
Head and Neck Cancer Lung Cancer Prostate Cancer Device: CT Scan

Detailed Description:

Cancer patients continue to represent a challenging disease population, which faces rather poor prognosis with current treatment planning and delivery practices. Venues for a potential dose escalation and/or increased healthy tissue sparing, through innovative therapeutic approaches for those patients, are clearly needed. Current state of the art radiotherapy treatment planning relies on the dose-volume-histogram (DVH) paradigm, where doses to fractional (most often) or absolute volumes of anatomical structures are employed in both optimization and plan evaluation process. It has been argued however, that the effects of delivered dose seem to be more closely related to healthy tissue toxicity (and thereby to clinical outcomes) when dose-mass-histograms (DMHs) are considered in treatment plan evaluation.

The investigators propose the incorporation of mass and density information explicitly into the cost functions of the inverse optimization process, thereby shifting from DVH to DMH treatment planning paradigm. This novel DMH-based intensity modulated radiotherapy (IMRT) optimization aims in minimization of radiation doses to a certain mass, rather than a volume, of healthy tissue. The investigators' working hypothesis is that DMH- optimization will reduce doses to healthy tissue substantially. In certain cases, with extensive, difficult to treat disease, lower doses to healthy tissue can be used for isotoxic dose escalation, which may result in an increase in estimated loco-regional tumor control probability.

To test the study hypothesis, the investigators will pursue the following specific aims:

  • (1) Develop the theoretical and computational framework of the DMH-based IMRT optimization. This framework will incorporate 3D and 4D IMRT as well as 3D volumetric modulated arc (VMAT) planning for different anatomical sites.
  • (2) Investigate different parametric forms for DMH-optimization functions. The ultimate goal would be the simultaneous minimization of healthy tissue doses and/or escalation of therapeutic doses, without violating the established dosimetric tolerances for healthy anatomical structures.
  • (3) Practical implementation and application of this novel optimization paradigm, where virtual clinical trials for cohorts of lung, head-and-neck, and prostate cancer cases will be performed.

Statistical significance of the DMH-optimization dosimetric improvements over standard of care DVH-optimization will be quantified. Prospective 3D and 4D CT data collection will be used to study the interactions between tumor time-trending changes and DMH-based optimization results. 4D CT data will also be used to investigate and quantify the correlation between DMH-based end points and the loss of pulmonary function during and after radiotherapy treatment. The deliverability (with the existing radiotherapy treatment equipment) of the investigators' 3D VMAT and 3D/4D IMRT plans will be experimentally verified, thereby paving the road for initiation of clinical trials.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: DMH-Based Plan Evaluation and Inverse Optimization in Radiotherapy
Actual Study Start Date : November 2013
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Group 1 - 3DCRT, VMAT, or IMRT
Study participants being treated according to the standard of care with either three-dimensional conformal radiotherapy (3DCRT), intensity modulated radiotherapy (IMRT), volumetric modulated arc therapy (VMAT). Several CT scans will be performed for each enrolled subject: one before the radiotherapy course for patient treatment planning purposes (as part of the standard of care), one during the radiotherapy treatment course (between fraction 10 and 20 for 3DCT, IMRT or VMAT patients), and one at follow up visit or at least 6 weeks post-radiotherapy treatment (whichever comes first).
Device: CT Scan
Other Name: Computed Tomography Imaging Scan
Experimental: Group 2 - SBRT
Study participants being treated according to the standard of care with Stereotactic Body Radiotherapy (SBRT). Several CT scans will be performed for each enrolled subject: one before the radiotherapy course for patient treatment planning purposes (as part of the standard of care), one during the radiotherapy treatment course (after fraction 3 for SBRT patients), and one at follow up visit or at least 6 weeks post-radiotherapy treatment (whichever comes first).
Device: CT Scan
Other Name: Computed Tomography Imaging Scan



Primary Outcome Measures :
  1. Radiation dose to tumors and healthy human tissue. [ Time Frame: Up to 4 years ]
    The study is computational in nature. A new treatment planning paradigm is proposed, but before its clinical implementation, this paradigm needs to be validated against current standard of care. From the treatment plans, computed with both this investigational approach and with the standard of care, radiation doses to different organs and tissues would be derived. Radiotherapy toxicity (to healthy human tissue) is proportional to radiation dose - more radiation dose results in higher toxicity. Thereby, if radiation dose is decreased, the toxicity would also be decreased. The dosimetric differences which the investigators observe between the standard of care and their novel optimization approach are reported both in percentages and in absolute radiation dose units. When the investigators observe decrease of radiation dose with their methodology to some normal tissue, they can convert that into estimates for complication rates based on radiobiological models.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically confirmed head-and-neck, lung, or prostate tumors.
  • Patients who will be treated with radiation therapy or concurrent chemoradiation therapy.
  • Gross Tumor Volume (GTV) or resection cavity must be visible on CT such that it can be delineated as a target for radiotherapy.
  • Patients who are able to understand the investigational nature of this study and agree to sign a written informed consent document.

Exclusion Criteria:

  • Pregnant or nursing women will not participate. Women of reproductive potential must be offered a pre-treatment pregnancy test and informed of the need to practice an effective contraceptive method during the therapy.
  • Patients younger than 18 years.
  • Patients whose size and weight would not allow CT scanning.
  • No vulnerable populations (fetuses, pregnant women, children, prisoners) will be included in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02663817


Contacts
Contact: Ivaylo Mihaylov, PhD 305-243-8223 i.mihaylov@med.miami.edu

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Ivaylo Mihaylov, PhD    305-243-8223    i.mihaylov@med.miami.edu   
Sub-Investigator: Matthew Abramowitz, MD         
Sub-Investigator: Elizabeth Brossart, MD         
Sub-Investigator: Nagy Elsayyad, MD         
Sub-Investigator: Adrian Ishkanian, MD         
Sub-Investigator: Michael Samuels, MD         
Sub-Investigator: Cristiane Takita, MD         
Sponsors and Collaborators
University of Miami
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ivaylo Mihaylov, PhD University of Miami

Responsible Party: Ivaylo Mihaylov, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT02663817     History of Changes
Other Study ID Numbers: 20130751
R01CA163370 ( U.S. NIH Grant/Contract )
First Posted: January 26, 2016    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms