CancerNCT01671163
Endoscopic Ultrasound-Guided Fiducial Placement for Stereotactic Body Radiotherapy
An observational study of Cancer, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate placing the radiation therapy markers (Fiducial) by using an endoscopic procedure. The endoscopic procedure is called an Endoscopic Ultrasound (EUS). This is a procedure using a special endoscope that has an ultrasound on the end. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Endoscopic Ultrasound (EUS) for fiducial placement
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to 12 Aug 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects who are currently scheduled to undergo fiducial placement at the University of Florida in Gainesville as medically indicated.
Who may be able to join
- Age 18 years or older,
- Scheduled to undergo fiducial placement,
- Subject must be able to give informed consent
Who cannot join
- Any contraindication to performing endoscopy,
- Participation in another research protocol that could interfere or influence the outcomes measures of the present study,
- The subject is unable/unwilling to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida/Shands
Gainesville, Florida, 32610
About this study
Official title: EUS-Guided Fiducial Placement for Stereotactic Body Radiotherapy
The purpose of this research study is to evaluate placing the radiation therapy markers (Fiducial) by using an endoscopic procedure. The endoscopic procedure is called an Endoscopic Ultrasound (EUS). This is a procedure using a special endoscope that has an ultrasound on the end. The ultrasound will allow the doctor's to see where the radiation therapy markers (Fiducial) is to be placed as outlined by the Radiation Oncologist.
- Conditions
- Cancer
- Being tested
- Endoscopic Ultrasound (EUS) for fiducial placement
- Keywords
- Cancer, Radiation therapy, Fiducial markers
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Ultrasound (EUS) for fiducial placementProcedure or surgery
Endoscopic Ultrasound (EUS) used for the placement of fiducial markers in tissue as outlined by the radiation oncologist
| Study group | Role | What they receive |
|---|---|---|
| Subjects requiring fiducial placement | Endoscopic Ultrasound (EUS) for fiducial placement Receives: Procedure: Endoscopic Ultrasound (EUS) for fiducial placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the success and accuracy of endoscopic delivery of the Fiducials into pre-selected targets using dedicated EUS fiducial delivery system.
The outcome measure for this study is to determine:
- The successful delivery, to the targeted tissue,of the fiducials through the fiducial delivery system,
- The accuracy of the fiducial delivery into the targeted tissue and
- to see if the fiducials can be visualized via Endoscopic Ultrasound (EUS), Fluoroscopy and/or CT scan.
The success and accuracy of the delivery will be evaluated by Endoscopic Ultrasound, fluoroscopy and/or CT scan to determine if the fiducials are in the targeted tissue. The subject's Oncologist will inform the endoscopist of the targeted tissue that is to receive the fiducials.
Measured: approximately one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2012 (estimated)
- Study startJul 2012
- Primary completion12 Aug 2019
- Study completion12 Aug 2019
Why it stopped: Insufficient enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter V Draganov, MD, Principal investigator, University of FloridaRobert Zlotecki, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671163
- Sponsor's protocol ID
- IRB201600243
- Other IDs
- 326-2012
- Status last verified
- Aug 2019
- First submitted
- 1 Aug 2012
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS-Guided Fiducial Placement for Stereotactic Body Radiotherapy
- ClinicalTrials.gov ID
- NCT01671163
- Acronym / sponsor ID
- IRB201600243
- Conditions
- Cancer
- Keywords
- Cancer, Radiation therapy, Fiducial markers
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- 12 Aug 2019 (actual)
- Study completion
- 12 Aug 2019 (actual)
- First posted
- 23 Aug 2012 (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.
The purpose of this research study is to evaluate placing the radiation therapy markers (Fiducial) by using an endoscopic procedure. The endoscopic procedure is called an Endoscopic Ultrasound (EUS). This is a procedure using a special endoscope that has an ultrasound on the end. The ultrasound will allow the doctor's to see where the radiation therapy markers (Fiducial) is to be placed as outlined by the Radiation Oncologist.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects requiring fiducial placement | – | Procedure: Endoscopic Ultrasound (EUS) for fiducial placementEndoscopic Ultrasound (EUS) for fiducial placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects who are currently scheduled to undergo fiducial placement at the University of Florida in Gainesville as medically indicated.
Key inclusion criteria (3 listed)
- Age 18 years or older,
- Scheduled to undergo fiducial placement,
- Subject must be able to give informed consent
Key exclusion criteria (3 listed)
- Any contraindication to performing endoscopy,
- Participation in another research protocol that could interfere or influence the outcomes measures of the present study,
- The subject is unable/unwilling to give informed consent
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 |
|---|---|---|
| Endoscopic Ultrasound (EUS) for fiducial placementEndoscopic Ultrasound (EUS) used for the placement of fiducial markers in tissue as outlined by the radiation oncologist | Procedure or surgery | Subjects requiring fiducial placement |
Primary outcome
Evaluation of the success and accuracy of endoscopic delivery of the Fiducials into pre-selected targets using dedicated EUS fiducial delivery system.
Time frame: approximately one week
The outcome measure for this study is to determine: 1. The successful delivery, to the targeted tissue,of the fiducials through the fiducial delivery system, 2. The accuracy of the fiducial delivery into the targeted tissue and 3. to see if the fiducials can be visualized via Endoscopic Ultrasound (EUS), Fluoroscopy and/or CT scan. The success and accuracy of the delivery will be evaluated by Endoscopic Ultrasound, fluoroscopy and/or CT scan to determine if the fiducials are in the targeted tissue. The subject's Oncologist will inform the endoscopist of the targeted tissue that is to receive the fiducials.
Results and safety
The study was stopped early (reason given: Insufficient enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
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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.
Peter V Draganov, MD principal investigator
University of Florida
Robert Zlotecki, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University of Florida 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 15 Aug 2019. 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?
The study was stopped early (reason given: Insufficient enrollment.). Results are not available in the source record.
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?
Evaluation of the success and accuracy of endoscopic delivery of the Fiducials into pre-selected targets using dedicated EUS fiducial delivery system. (time frame: approximately one week). 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 15 Aug 2019.