DMH-Based Plan Evaluation and Inverse Optimization in Radiotherapy

NCT02663817 | Completed Results FDA Device

• 2 other identifiers: 20130751R01CA163370
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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)

Conditions

Head and Neck Cancer; Lung Cancer; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, up to three years.

Study Arms (1)

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).

Device: CT Scan

Interventions

CT Scan DEVICE

Also known as: Computed Tomography Imaging Scan

IMRT

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Lung Neoplasms; Prostatic Neoplasms

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Results Point of Contact

• Title: Dr. Ivaylo Mihaylov
• Organization: University of Miami

i.mihaylov@med.miami.edu

305-243-8223

Study Officials

• Ivaylo Mihaylov, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: January 26, 2016
• Study Start: June 19, 2015
• Primary Completion: April 4, 2019
• Study Completion: April 4, 2019
• Last Updated: February 5, 2020
• Results First Posted: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)