Clinical Evaluation of a Laser Heated, Fiberoptic-Coupled Radiation Dose Verification System

NCT ID: NCT00026871

Last Updated: 2008-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-07-31

Study Completion Date

2006-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

We propose to determine the response of a newly developed laser heated, vycor glass fiberoptic radiation dosimetry system to ionizing radiation in a clinical radiotherapy environment. Present systems measure only total dose or have limitations, such as instability, non-linearity, excessive size or a decoupled measurement system, making them unsuitable in a variety of clinical applications. This fiberoptic coupled dosimetry system is a new and innovative technology application which allows on-line measurement of instantaneous dose rate and total dose never before achievable. It offers a clear advantage in patient treatment delivery, allowing on-line corrections essential to a new generation of radiotherapy treatment machines with development of beam intensity modulation as an adjunct to 3D conformal therapy. It also has the advantage of submillimeter size and is minimally invasive, making it ideal for brachytherapy.

This system has the potential for stable, accurate, reproducible, clinically feasible measurements of total dose and dose rate. The output of this system will be measured under various clinical conditions encountered in a clinical setting and compared against existing thermolumeniscent and diode dosimetry standards. Initial measurements will use a tissue equivalent phantom for depth dose and accuracy measurements. Additional studies will include dosimetric measurements of routine clinical treatment setups on patients receiving therapeutic irradiation.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

We propose to determine the response of a newly developed laser heated, vycor glass fiberoptic radiation dosimetry system to ionizing radiation in a clinical radiotherapy environment. Present systems measure only total dose or have limitations, such as instability, non-linearity, excessive size or a decoupled measurement system, making them unsuitable in a variety of clinical applications. This fiberoptic coupled dosimetry system is a new and innovative technology application which allows on-line measurement of instantaneous dose rate and total dose never before achievable. It offers a clear advantage in patient treatment delivery, allowing on-line corrections essential to a new generation of radiotherapy treatment machines with development of beam intensity modulation as an adjunct to 3D conformal therapy. It also has the advantage of submillimeter size and is minimally invasive, making it ideal for brachytherapy.

This system has the potential for stable, accurate, reproducible, clinically feasible measurements of total dose and dose rate. The output of this system will be measured under various clinical conditions encountered in a clinical setting and compared against existing thermolumeniscent and diode dosimetry standards. Initial measurements will use a tissue equivalent phantom for depth dose and accuracy measurements. Additional studies will include dosimetric measurements of routine clinical treatment setups on patients receiving therapeutic irradiation.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Primary Study Purpose

TREATMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Radiotherapy

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Patients receiving either external beam radiotherapy or a radioactive implant under established primary clinical protocols at the NCI or the National Naval Medical Center.

Patients must be willing to have the additional measurements performed and sign an informed consent.

Exclusion Criteria

Pediatric and cognitively impaired subjects will not be eligible for this study.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role lead

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Cancer Institute (NCI)

Bethesda, Maryland, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

97-C-0129

Identifier Type: -

Identifier Source: secondary_id

970129

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.