NeoplasmPhase 1NCT00026871
Clinical Evaluation of a Laser Heated, Fiberoptic-Coupled Radiation Dose Verification System
A Phase 1 study testing Radiotherapy in people with Neoplasm, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neoplasm
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1997to May 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pediatric and cognitively impaired subjects will not be eligible for this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
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.
Read the detailed description
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
- Neoplasm
- Being tested
- Radiotherapy
- Keywords
- Non-Therapeutic, Radiation Therapy, Dosimetry, Dose-Rate, Fiberoptic
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2001 (estimated)
- Study startJul 1997
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00026871
- Sponsor's protocol ID
- 970129
- Other IDs
- 97-C-0129
- Status last verified
- May 2006
- First submitted
- 14 Nov 2001
- Last updated
- 4 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Laser Heated, Fiberoptic-Coupled Radiation Dose Verification System
- ClinicalTrials.gov ID
- NCT00026871
- Acronym / sponsor ID
- 970129
- Conditions
- Neoplasm
- Keywords
- Non-Therapeutic, Radiation Therapy, Dosimetry, Dose-Rate, Fiberoptic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jul 1997
- Study completion
- May 2006
- First posted
- 15 Nov 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Pediatric and cognitively impaired subjects will not be eligible for 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 |
|---|---|---|
| Radiotherapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Radiotherapy in people with Neoplasm, run by National Cancer Institute (NCI) 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 2 inclusion and 1 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 4 Mar 2008. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 4 Mar 2008.