InfectionNCT01287013
Comparing Xperguide vs. Conventional Methods During Percutaneous Image Guided Procedures
A study testing Cone-beam computed tomography (CT) and Conventional Computed Tomography (CT) in people with Infection and Cancer, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Background: Procedures that use medical tools in or near a possible abnormality in the body often use computed tomography (CT) scans to locate the abnormality and guide the path that a needle will take to collect a sample of tissue. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- What is being tested?
- Cone-beam computed tomography (CT) and Conventional Computed Tomography (CT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Aug 2015
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- they are over 18 years of age
- they are scheduled for image guided procedure
- the lesion is not superficial (deeper than 3 cm)
Who cannot join
- patients with an altered mental status that precludes understanding or consenting for the procedure
- patients unable to hold reasonably still on a procedure table for the length of the procedure
- patient unable to hold their breath if the procedure will be performed with conscious sedation and without general anesthesia
- patient with a gross body weight over 375 pounds (upper limit of the CT and angiography tables)
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Prospective Randomized Trial Comparing Navigation With Xperguide vs. Conventional Methods During Percutaneous Image Guided Procedures
Background:
- Procedures that use medical tools in or near a possible abnormality in the body often use computed tomography (CT) scans to locate the abnormality and guide the path that a needle will take to collect a sample of tissue. Xperguide and electromagnetic (EM) tracking are two new procedures being studied to help guide the needle. Xperguide is software that uses CT images to help the doctor choose the needle path. EM tracking uses special medical tools with miniature coils that act like a Global Positioning Satellite (GPS) device to show the location of the needle in the body. Xperguide and EM tracking have been used in humans and have good results, but they have not been compared with each other and regular CT to determine whether they are better than the standard approach.
Read more
Objectives:
- To compare the results of Xperguide, electromagnetic tracking, and regular computed tomography during a guided percutaneous procedure.
Eligibility:
- Individuals at least 18 years of age who are required to have a CT-guided percutaneous procedure.
Design:
- Participants will be screened with a physical examination and medical history, and the results of any previous imaging studies will be examined before study enrollment.
- After a pilot phase, the study will involve two phases to compare the results of the different procedures. The first phase will involve comparing Xperguide to CT, and the second will involve comparing Xperguide to EM tracking.
- Phase 1 participants will be assigned to one of two procedure groups: Group 1 will have Xperguide, and Group 2 will have regular CT. Participants who are scheduled to have repeated procedures (like a biopsy before and after chemotherapy) will be randomized for the first procedure and the second procedure will be done using the other method.
- Phase 2 participants will be assigned to one of two procedure groups: Group 1 will have Xperguide, and Group 2 will have EM tracking. Participants who are scheduled to have repeated procedures (like a biopsy before and after chemotherapy) will be randomized for the first procedure and the second procedure will be done using the other method.
- Standard post-procedure followup care will be given after the study procedure is completed.
Read the detailed description
PR(SqrRoot) CIS
This is a phase II prospective randomized trial comparing a novel navigation method, Xperguide to conventional CT and electromagnetic tracking (EM) during percutaneous image guided procedures. Xperguide is a navigation tool that utilizes a cone beam CT (CBCT) obtained in the angiography suite overlaid on fluoroscopy for needle guidance during image guided procedures. The needle entry point and path are planned on the CBCT and the determined path is overlaid on fluoroscopy image for real time guidance.
SPECIFIC AIMS/OBJECTIVES
- The primary aims are:
- Pilot trial:
- To familiarize operators with outcome measures allowing for fair comparison in the subsequent study
- Main trial will have 2 phases with similar outcomes criteria and aims (below):
- comparing Xperguide to conventional imaging (superiority design): ii. comparing Xperguide to EM tracking (equivalence design):
- To compare the accuracy of final device tip position and path (vector)
- To compare the number of repositioning maneuvers
- To compare the radiation dose
- To compare rates of definitive pathological diagnosis and response rate per EASL criteria for ablations
METHODS/METHODOLOGY
For non-vascular image guided interventions, patients undergoing biopsies and ablations procedures requiring CT guidance are eligible for inclusion and randomization. An initial pilot study will be done in which each operator will perform at least 5 cases using Xperguide completing the case report forms. This will ensure experience with outcome measures and fair comparison in the subsequent study. Once one of the operators reaches the minimal required cases, the main trial will begin for that operator. However every other operator must each complete the minimal number of cases with the case report forms to enroll patients in the main trial. Initially, we will compare Xperguide with conventional CT with several cohorts of patients mainly: lung biopsies, and ablations, kidney biopsies/ablations and other abdominal biopsies/ ablations. In ablations of large lesions, Xperguide composite ablation software can provide input on the expected ablation zones. Each probe will be positioned in the same manner as any biopsy needle following steps described in section 4. If this specific composite ablation module of the
software is not commercially released and FDA cleared at the time of the study, then this software will only be used on protocol to help the physician determine ideal needle positioning for complete ablation. Once consent is obtained the participant is randomized to either conventional imaging or Xperguide. In addition, if it is known that the patient is participating in a trial which requires a repeat (paired, pre and post treatment) procedure of the same site, then the randomization will determine which modality is used for guidance at the first visit and the other modality will automatically be used for the second procedure. In these cases, if the patient gives consent they will be randomized to one of two categories:
- Xperguide for the initial procedure and conventional CT for the 2nd procedure
- Conventional CT for the initial procedure and Xperguide for the 2nd procedure
Then in the second phase of the trial, Xperguide will be compared to EM tracking for biopsies and ablations requiring CT guidance, in an equivalence study. Once consent is obtained, the participant will be randomized into EM tracking or Xperguide. The patients would be divided into different cohorts depending on the anatomic site of the interventions i.e. lung, kidney, liver and other abdomen. If the patients are participating in a trial requiring paired procedures (i.e. pre and post treatment), the randomization will determine which modality is used for the initial procedure and the other modality will be used for the second procedure. In summary there will be two potential categories:
- EM tracking for the initial procedure and Xperguide for the 2nd procedure
- Xperguide for the initial procedure and EM tracking for the 2nd procedure
If a patient has a lesion that is only visible on PET-CT/MR, or demonstrates heterogenous PET-CT/MR uptake, there will be a separate cohort of PET-CT/MR guided biopsies and ablations using Xperguide vs EM tracking. There is also the need for a cohort for ablations with complimentary use of ultrasound at the discretion of the operator in order to conform to our standard of care at the NIH.
ELIGIBILITY
Subjects are eligible if:
- they are over 18 years of age
- they are scheduled for image guided procedure
- the lesion is not superficial (deeper than 3cm)
Subjects are excluded if:
- they have an altered mental status that precludes understanding or consenting for the procedure
- they are unable to hold reasonably still on a procedure table for the length of the procedure
- they are unable to hold their breath if the procedure will be performed with conscious sedation and without general anesthesia
- their gross body weight is over 375 pounds which the upper limit of the CT and angiography tables
REQUIRED SAMPLE SIZE
A pilot study will be performed to ensure operator experience with Xperguide and EM tracking, for fair comparison. In the pilot study each operator must perform 5 cases with Xperguide completing the case report forms. There are 5 potential operators therefore a maximum of 25 patients (if all 5 operators participate to the fullest).
The first phase of the main trial comparing Xperguide with conventional CT was powered (for sample size) with a standard superiority design aimed to statistically establish that Xperguide is better than conventional CT (defined as requiring fewer needle repositioning efforts). These calculations yield a total sample size of 60 patients with 20 patients per anatomical site.
For the second phase of the trial comparing Xperguide to EM tracking, a two sided equivalence design (based on accuracy and number of needle repositioning) was used for sample size considerations, and yielded 192 patients. Therefore 16 patients per modality per anatomical site will be randomized with two additional cohorts for PET-CT/MR procedures and composite ablations.
Number of Participants: 277
Recruitment Time Frame: 4 years
Number of sites: 1
Type of Study: prospective randomized clinical trial after an initial pilot period
- Being tested
- Cone-beam computed tomography (CT), Conventional Computed Tomography (CT)
- Keywords
- Image Guided Procedures, Xperguide CT, Electromagnetic Tracking, Navigation, Image Guided Procedure, Cancer, Granuloma
- Medical subject headings
- Infections, Neoplasms, Empyema, Granuloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cone-beam computed tomography (CT)Device
Also called XperCT (Philips, Best), XperGuide CT
Imaging
Conventional Computed Tomography (CT)Device
Also called Conventional CT (Philips)
Imaging
| Study group | Role | What they receive |
|---|---|---|
| Cone Beam CT | Other | Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation Receives: Device: Cone-beam computed tomography (CT) |
| Conventional CT | Other | Procedure performed with Conventional Computed Tomography (CT) image guidance Receives: Device: Conventional Computed Tomography (CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the Accuracy of Final Device Tip Position
To compare the accuracy of the biopsy needle between the software guidance and conventional CT. The accuracy of the needle position was calculated in millimeters by using the difference between the x,y,z coordinates of the tip of the actual needle before specimen collection. Actual and planned needle paths were compared using coordinates and measured in millimeters.
Measured: 1 hour
Accuracy of Final Device Path (Vector)
Comparing the accuracy of the path the biopsy needle took to get to the site
Measured: 1 hour
Radiation Doses Between Xperguide and Conventional CT
Comparing radiation doses to determine if there is a change in the dose between the two interventions
Measured: 1 hour
Secondary outcomes (2)
Compare the Number of Repositioning Maneuvers
To compare the number of times the needle must be repositioned during the guidance of the needle to the biopsy.
Measured: 1 hour
Rates of Definitive Pathologic Diagnosis
Definitive pathologic diagnosis was defined as an adequate specimen as judged by the pathologist and a diagnosis confirmed by surgery or clinical follow-up.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: Investigator left NIH
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Bradford Wood, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287013
- Sponsor's protocol ID
- 110082
- Other IDs
- 110082
- Status last verified
- Oct 2017
- First submitted
- 25 Jan 2011
- Last updated
- 5 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Carrafiello G, Mangini M, De Bernardi I, Fontana F, Dionigi G, Cuffari S, Imperatori A, Lagana D, Fugazzola C. Microwave ablation therapy for treating primary and secondary lung tumours: technical note. Radiol Med. 2010 Sep;115(6):962-74. doi: 10.1007/s11547-010-0547-7. Epub 2010 Mar 29. English, Italian.
PubMed 20352357Racadio JM, Babic D, Homan R, Rampton JW, Patel MN, Racadio JM, Johnson ND. Live 3D guidance in the interventional radiology suite. AJR Am J Roentgenol. 2007 Dec;189(6):W357-64. doi: 10.2214/AJR.07.2469.
PubMed 18029850Spelle L, Ruijters D, Babic D, Homan R, Mielekamp P, Guillermic J, Moret J. First clinical experience in applying XperGuide in embolization of jugular paragangliomas by direct intratumoral puncture. Int J Comput Assist Radiol Surg. 2009 Nov;4(6):527-33. doi: 10.1007/s11548-009-0370-6. Epub 2009 Jun 13.
PubMed 20033329Abi-Jaoudeh N, Fisher T, Jacobus J, Skopec M, Radaelli A, Van Der Bom IM, Wesley R, Wood BJ. Prospective Randomized Trial for Image-Guided Biopsy Using Cone-Beam CT Navigation Compared with Conventional CT. J Vasc Interv Radiol. 2016 Sep;27(9):1342-1349. doi: 10.1016/j.jvir.2016.05.034. Epub 2016 Jul 25.
PubMed 27461586
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial Comparing Navigation With Xperguide vs. Conventional Methods During Percutaneous Image Guided Procedures
- ClinicalTrials.gov ID
- NCT01287013
- Acronym / sponsor ID
- 110082
- Keywords
- Image Guided Procedures, Xperguide CT, Electromagnetic Tracking, Navigation, Image Guided Procedure, Cancer, Granuloma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator left NIH
- Enrolment
- 87 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- Jan 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 1 Feb 2011 (estimated)
- Results
- Posted 5 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Procedures that use medical tools in or near a possible abnormality in the body often use computed tomography (CT) scans to locate the abnormality and guide the path that a needle will take to collect a sample of tissue. Xperguide and electromagnetic (EM) tracking are two new procedures being studied to help guide the needle. Xperguide is software that uses CT images to help the doctor choose the needle path. EM tracking uses special medical tools with miniature coils that act like a Global Positioning Satellite (GPS) device to show the location of the needle in the body. Xperguide and EM tracking have been used in humans and have good results, but they have not been compared with each other and regular CT to determine whether they are better than the standard approach.
Objectives:
- To compare the results of Xperguide, electromagnetic tracking, and regular computed tomography during a guided percutaneous procedure.
Eligibility:
- Individuals at least 18 years of age who are required to have a CT-guided percutaneous procedure.
Design:
- Participants will be screened with a physical examination and medical history, and the results of any previous imaging studies will be examined before study enrollment.
- After a pilot phase, the study will involve two phases to compare the results of the different procedures. The first phase will involve comparing Xperguide to CT, and the second will involve comparing Xperguide to EM tracking.
- Phase 1 participants will be assigned to one of two procedure groups: Group 1 will have Xperguide, and Group 2 will have regular CT. Participants who are scheduled to have repeated procedures (like a biopsy before and after chemotherapy) will be randomized for the first procedure and the second procedure will be done using the other method.
- Phase 2 participants will be assigned to one of two procedure groups: Group 1 will have Xperguide, and Group 2 will have EM tracking. Participants who are scheduled to have repeated procedures (like a biopsy before and after chemotherapy) will be randomized for the first procedure and the second procedure will be done using the other method.
- Standard post-procedure followup care will be given after the study procedure is completed.
Detailed description
PR(SqrRoot) CIS
This is a phase II prospective randomized trial comparing a novel navigation method, Xperguide to conventional CT and electromagnetic tracking (EM) during percutaneous image guided procedures. Xperguide is a navigation tool that utilizes a cone beam CT (CBCT) obtained in the angiography suite overlaid on fluoroscopy for needle guidance during image guided procedures. The needle entry point and path are planned on the CBCT and the determined path is overlaid on fluoroscopy image for real time guidance.
SPECIFIC AIMS/OBJECTIVES
- The primary aims are:
- Pilot trial:
- To familiarize operators with outcome measures allowing for fair comparison in the subsequent study
- Main trial will have 2 phases with similar outcomes criteria and aims (below):
- comparing Xperguide to conventional imaging (superiority design): ii. comparing Xperguide to EM tracking (equivalence design):
- To compare the accuracy of final device tip position and path (vector)
- To compare the number of repositioning maneuvers
- To compare the radiation dose
- To compare rates of definitive pathological diagnosis and response rate per EASL criteria for ablations
METHODS/METHODOLOGY
For non-vascular image guided interventions, patients undergoing biopsies and ablations procedures requiring CT guidance are eligible for inclusion and randomization. An initial pilot study will be done in which each operator will perform at least 5 cases using Xperguide completing the case report forms. This will ensure experience with outcome measures and fair comparison in the subsequent study. Once one of the operators reaches the minimal required cases, the main trial will begin for that operator. However every other operator must each complete the minimal number of cases with the case report forms to enroll patients in the main trial. Initially, we will compare Xperguide with conventional CT with several cohorts of patients mainly: lung biopsies, and ablations, kidney biopsies/ablations and other abdominal biopsies/ ablations. In ablations of large lesions, Xperguide composite ablation software can provide input on the expected ablation zones. Each probe will be positioned in the same manner as any biopsy needle following steps described in section 4. If this specific composite ablation module of the
software is not commercially released and FDA cleared at the time of the study, then this software will only be used on protocol to help the physician determine ideal needle positioning for complete ablation. Once consent is obtained the participant is randomized to either conventional imaging or Xperguide. In addition, if it is known that the patient is participating in a trial which requires a repeat (paired, pre and post treatment) procedure of the same site, then the randomization will determine which modality is used for guidance at the first visit and the other modality will automatically be used for the second procedure. In these cases, if the patient gives consent they will be randomized to one of two categories:
- Xperguide for the initial procedure and conventional CT for the 2nd procedure
- Conventional CT for the initial procedure and Xperguide for the 2nd procedure
Then in the second phase of the trial, Xperguide will be compared to EM tracking for biopsies and ablations requiring CT guidance, in an equivalence study. Once consent is obtained, the participant will be randomized into EM tracking or Xperguide. The patients would be divided into different cohorts depending on the anatomic site of the interventions i.e. lung, kidney, liver and other abdomen. If the patients are participating in a trial requiring paired procedures (i.e. pre and post treatment), the randomization will determine which modality is used for the initial procedure and the other modality will be used for the second procedure. In summary there will be two potential categories:
- EM tracking for the initial procedure and Xperguide for the 2nd procedure
- Xperguide for the initial procedure and EM tracking for the 2nd procedure
If a patient has a lesion that is only visible on PET-CT/MR, or demonstrates heterogenous PET-CT/MR uptake, there will be a separate cohort of PET-CT/MR guided biopsies and ablations using Xperguide vs EM tracking. There is also the need for a cohort for ablations with complimentary use of ultrasound at the discretion of the operator in order to conform to our standard of care at the NIH.
ELIGIBILITY
Subjects are eligible if:
- they are over 18 years of age
- they are scheduled for image guided procedure
- the lesion is not superficial (deeper than 3cm)
Subjects are excluded if:
- they have an altered mental status that precludes understanding or consenting for the procedure
- they are unable to hold reasonably still on a procedure table for the length of the procedure
- they are unable to hold their breath if the procedure will be performed with conscious sedation and without general anesthesia
- their gross body weight is over 375 pounds which the upper limit of the CT and angiography tables
REQUIRED SAMPLE SIZE
A pilot study will be performed to ensure operator experience with Xperguide and EM tracking, for fair comparison. In the pilot study each operator must perform 5 cases with Xperguide completing the case report forms. There are 5 potential operators therefore a maximum of 25 patients (if all 5 operators participate to the fullest).
The first phase of the main trial comparing Xperguide with conventional CT was powered (for sample size) with a standard superiority design aimed to statistically establish that Xperguide is better than conventional CT (defined as requiring fewer needle repositioning efforts). These calculations yield a total sample size of 60 patients with 20 patients per anatomical site.
For the second phase of the trial comparing Xperguide to EM tracking, a two sided equivalence design (based on accuracy and number of needle repositioning) was used for sample size considerations, and yielded 192 patients. Therefore 16 patients per modality per anatomical site will be randomized with two additional cohorts for PET-CT/MR procedures and composite ablations.
Number of Participants: 277
Recruitment Time Frame: 4 years
Number of sites: 1
Type of Study: prospective randomized clinical trial after an initial pilot period
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cone Beam CT | Other | Device: Cone-beam computed tomography (CT)Procedure performed with Xperguide cone-beam Computed Tomography (CT) navigation |
| Conventional CT | Other | Device: Conventional Computed Tomography (CT)Procedure performed with Conventional Computed Tomography (CT) image guidance |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
Key exclusion criteria (4 listed)
- patients with an altered mental status that precludes understanding or consenting for the procedure
- patients unable to hold reasonably still on a procedure table for the length of the procedure
- patient unable to hold their breath if the procedure will be performed with conscious sedation and without general anesthesia
- patient with a gross body weight over 375 pounds (upper limit of the CT and angiography tables)
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 |
|---|---|---|
| Cone-beam computed tomography (CT)Also: XperCT (Philips, Best), XperGuide CTImaging | Device | Cone Beam CT |
| Conventional Computed Tomography (CT)Also: Conventional CT (Philips)Imaging | Device | Conventional CT |
Primary outcome
Comparing the Accuracy of Final Device Tip Position
Time frame: 1 hour
To compare the accuracy of the biopsy needle between the software guidance and conventional CT. The accuracy of the needle position was calculated in millimeters by using the difference between the x,y,z coordinates of the tip of the actual needle before specimen collection. Actual and planned needle paths were compared using coordinates and measured in millimeters.
Accuracy of Final Device Path (Vector)
Time frame: 1 hour
Comparing the accuracy of the path the biopsy needle took to get to the site
Radiation Doses Between Xperguide and Conventional CT
Time frame: 1 hour
Comparing radiation doses to determine if there is a change in the dose between the two interventions
2 secondary outcomes
Compare the Number of Repositioning Maneuvers
Time frame: 1 hour
Rates of Definitive Pathologic Diagnosis
Time frame: 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20352357Carrafiello G, Mangini M, De Bernardi I, Fontana F, Dionigi G, Cuffari S, Imperatori A, Lagana D, Fugazzola C. Microwave ablation therapy for treating primary and secondary lung tumours: technical note. Radiol Med. 2010 Sep;115(6):962-74. doi: 10.1007/s11547-010-0547-7. Epub 2010 Mar 29. English, Italian.
- Background: PubMed 18029850Racadio JM, Babic D, Homan R, Rampton JW, Patel MN, Racadio JM, Johnson ND. Live 3D guidance in the interventional radiology suite. AJR Am J Roentgenol. 2007 Dec;189(6):W357-64. doi: 10.2214/AJR.07.2469.
- Background: PubMed 20033329Spelle L, Ruijters D, Babic D, Homan R, Mielekamp P, Guillermic J, Moret J. First clinical experience in applying XperGuide in embolization of jugular paragangliomas by direct intratumoral puncture. Int J Comput Assist Radiol Surg. 2009 Nov;4(6):527-33. doi: 10.1007/s11548-009-0370-6. Epub 2009 Jun 13.
- Results publication: PubMed 27461586Abi-Jaoudeh N, Fisher T, Jacobus J, Skopec M, Radaelli A, Van Der Bom IM, Wesley R, Wood BJ. Prospective Randomized Trial for Image-Guided Biopsy Using Cone-Beam CT Navigation Compared with Conventional CT. J Vasc Interv Radiol. 2016 Sep;27(9):1342-1349. doi: 10.1016/j.jvir.2016.05.034. Epub 2016 Jul 25.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- 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.
Bradford Wood, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cone-beam computed tomography (CT) and Conventional Computed Tomography (CT) in people with Infection and Cancer, run by National Institutes of Health Clinical Center (CC) 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 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: stopped early, as of the sponsor's last update on 5 Jan 2018. 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 Jan 2018). 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?
Comparing the Accuracy of Final Device Tip Position (time frame: 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01287013, which also lists 4 linked publications.
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 Jan 2018.