DMH-Based Plan Evaluation and Inverse Optimization in Radiotherapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02663817|
Recruitment Status : Recruiting
First Posted : January 26, 2016
Last Update Posted : February 7, 2018
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|
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|
|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|
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
- 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.
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
|Contact: Ivaylo Mihaylov, PhDemail@example.com|
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Ivaylo Mihaylov, PhD 305-243-8223 firstname.lastname@example.org|
|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|
|Principal Investigator:||Ivaylo Mihaylov, PhD||University of Miami|