Head and Neck CancerNCT02663817
DMH-Based Plan Evaluation and Inverse Optimization in Radiotherapy
A study testing CT Scan in people with Head and Neck Cancer and Lung Cancer, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Lung Cancer, Prostate Cancer
- What is being tested?
- CT Scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2015to 4 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
Read the 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.
- Conditions
- Head and Neck Cancer, Lung Cancer, Prostate Cancer
- Being tested
- CT Scan
- Medical subject headings
- Head and Neck Neoplasms, Lung Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT ScanDevice
Also called Computed Tomography Imaging Scan
| Study group | Role | What they receive |
|---|---|---|
| IMRT | Experimental | Study participants being treated according to the standard of care with intensity modulated radiotherapy (IMRT). 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), and one at follow up visit or at least 6 weeks post-radiotherapy treatment (whichever comes first). Receives: Device: CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Radiation Dose to Healthy Human Tissue.
The study is computational in nature. A new treatment planning paradigm is proposed, where from the newly proposed treatment plans, and the treatment plans generated 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 as percent change with respect to the standard of care.
Measured: Baseline, up to three years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study start19 Jun 2015
- Primary completion4 Apr 2019
- Study completion4 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Ivaylo Mihaylov, PhD, DABR, University of Miami
- Investigators
- Ivaylo Mihaylov, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663817
- Sponsor's protocol ID
- 20130751
- Other IDs
- R01CA163370
- Status last verified
- Jan 2020
- First submitted
- 19 Jan 2016
- Last updated
- 5 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DMH-Based Plan Evaluation and Inverse Optimization in Radiotherapy
- ClinicalTrials.gov ID
- NCT02663817
- Acronym / sponsor ID
- 20130751
- Conditions
- Head and Neck Cancer, Lung Cancer, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Jun 2015 (actual)
- Primary completion
- 4 Apr 2019 (actual)
- Study completion
- 4 Apr 2019 (actual)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Posted 5 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMRT | Experimental | Device: CT ScanStudy participants being treated according to the standard of care with intensity modulated radiotherapy (IMRT). 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), and one at follow up visit or at least 6 weeks post-radiotherapy treatment (whichever comes first). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT ScanAlso: Computed Tomography Imaging Scan | Device | IMRT |
Primary outcome
Percent Change in Radiation Dose to Healthy Human Tissue.
Time frame: Baseline, up to three years.
The study is computational in nature. A new treatment planning paradigm is proposed, where from the newly proposed treatment plans, and the treatment plans generated 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 as percent change with respect to the standard of care.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivaylo Mihaylov, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT Scan in people with Head and Neck Cancer and Lung Cancer, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Radiation Dose to Healthy Human Tissue. (time frame: Baseline, up to three years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.