Image-Guided SurgeryPhase 2NCT01818440
Fluoroscopy or 3-D Roadmap Imaging Software for Liver Tumor Treatment
A Phase 2 study testing 3D Roadmap software and Fluoroscopy in people with Image-Guided Surgery, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Background: Researchers are interested in comparing two methods that doctors can use to position catheters in blood vessels. These methods are used to deliver chemotherapy and close the blood supply to a tumor. The methods are the standard method called fluoroscopy and a new way called 3-D Roadmap. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Image-Guided Surgery
- What is being tested?
- 3D Roadmap software and Fluoroscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2013to 22 Aug 2018
- Phase
- Phase 2
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have primary or metastatic hepatic tumors scheduled for trans-arterial chemo-embolization or bland embolization in interventional radiology. A multi-disciplinary team including oncology, surgery, pathology and radiation oncology as well as interventional radiology will review each candidate and determine the eligibility for TACE or bland embolization and ineligibility for other interventions.
- Age >18 years
- They must be eligible for trans-arterial chemoembolization or bland embolization
Who cannot join
- Patients with an altered mental status precluding understanding or consenting for the procedure
- History of allergic reactions to iodine contrast, which cannot be controlled by premedication with antihistamines and steroids.
- Pregnant women are excluded from the study because ionizing radiation is teratogenic or abortifacient effects. Patients are excluded from pregnancy testing if they are above the childbearing age of 55 years old, or if they have documented history of infertility or acquired or congenital disorders incompatible with pregnancy or if the patient has had a hysterectomy or bilateral oophorectomy. Patients are also excluded from pregnancy testing if they are at least 50 years of age AND have not menstruated for at least 12 months OR have a documented Follicle Stimulating Hormone (FSH) level of greater than 40 mIU/mL.
- Patients with a total body weight exceeding 375 pounds since that is the weight limit of the angiography table.
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 3D Roadmap vs. Conventional Angiography During Transarterial Embolization
Background:
- Researchers are interested in comparing two methods that doctors can use to position catheters in blood vessels. These methods are used to deliver chemotherapy and close the blood supply to a tumor. The methods are the standard method called fluoroscopy and a new way called 3-D Roadmap. The 3-D Roadmap software uses computed tomography (CT) images to help the doctor choose the best position for the catheter to get to the tumor. The computer shows the route on an x-ray screen in real time. This technique may help doctors position the catheter with less x-ray dye and in a shorter time. These methods will be compared in people who are having a procedure to destroy liver tumors. The procedure, called trans-arterial embolization, will deliver chemotherapy and destroy the tumor blood supply.
Read more
Objectives:
- To compare the effectiveness of fluoroscopy or 3-D Roadmap software for liver tumor treatment.
Eligibility:
- Individuals at least 18 years of age who are having trans-arterial embolization for liver cancer.
Design:
- Participants will be screened with a physical exam and medical history. They will provide blood and urine samples, and have imaging studies.
- Participants will be divided into two groups. One group will have regular fluoroscopy (X-ray) during the procedure. The other group will have the procedure with the 3-D Roadmap software.
- In the first group, participants will have a CT scan. The doctor will decide how many vessels need to be treated. The doctor will advance the catheter using fluoroscopy only. Another CT scan will be given after the procedure.
- In the second group, participants will have a CT scan. The doctor will look at the scan with the 3-D Roadmap software. The software will show the path to advance the catheter. The doctor will use the software to help destroy the tumors. Another CT scan will be given after the procedure.
- Both groups will have the same follow-up care afterward. Other tests will be given as needed for the cancer treatment.
Read the detailed description
Background:
This is a phase II prospective randomized trial comparing novel tumor segmentation and navigation with 3D roadmap vs. conventional imaging with angiography during trans-arterial embolization procedures. Cone beam CT (CBCT) obtains CT-like images in the angiography suite during trans-arterial chemoembolization procedures and liver chemo-perfusion (PHP). In addition, 2D liver perfusion metrics can be calculated from angiography images. 3D Roadmap is a navigation tool/ software that utilize the data from the CBCT overlaid on live fluoroscopy to display a segmented tumor, delineate its vascular supply and to navigate catheters to the target vessels. Moreover, with 3D Roadmap, CBCT can be fused to prior CT or MRI for improved target visualization. The 3D Roadmap software received 510 (k) clearance on February 19, 2004. Our CRADA partner, Philips Healthcare, also submitted and received a separate 510 (k) clearance on January 30, 2015 for the software s vessel segmentation functionality and is under the trade name Emboguide. 3D Roadmap/ Emboguide software is intended to be used in combination with the AlluraClarity X-ray system.
Primary Objective:
To compare safety, and technical efficiency of navigation with 3D Roadmap vs. conventional image guidance during trans-arterial embolization procedures.
Eligibility:
Subjects are eligible if:
- They are more than 18 years of age
- They have primary or metastatic hepatic tumors scheduled for trans-arterial chemo- embolization or bland embolization in interventional radiology
- They are eligible for trans-arterial chemoembolization or bland embolization
Subjects are excluded if they have:
- An altered mental status precluding understanding or consenting for the procedure
- Contra-indications to trans-arterial embolization
- A gross body weight exceeding 375 pounds (upper limit of angio table)
- A pregnancy
- A severe allergic reaction to iodine contrast which cannot be controlled by premedication with antihistamines and steroids
Design:
- Number of Participants: 30
- Recruitment Time Frame: 2 years
- Number of sites: 1
- Type of Study: prospective randomized clinical trial
- Conditions
- Image-Guided Surgery
- Being tested
- 3D Roadmap software, Fluoroscopy
- Keywords
- Surgical Navigation, Liver, Cancer, Image-guided Therapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Roadmap softwareOther
Two scanning methods will be used by doctors to position catheters in the blood vessels to deliver the chemotherapy and close the blood supply to the tumor.
FluoroscopyOther
Patients will have the procedure performed with regular fluoroscopy (X-ray). Regular fluoroscopy is the standard method.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Patients will have the procedure performed with regular fluoroscopy (X-ray). Regular fluoroscopy is the standard method Receives: Other: Fluoroscopy |
| B | Experimental | Patients will have the procedure performed using the 3-D Roadmap software.With the 3DRoadmap, images from a Cone-Beam CT are analyzed. Software shows the vessels supplying the tumor and the plan is displayed on top of fluoroscopy Receives: Other: 3D Roadmap software |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare safety, efficacy, and technical efficiency of navigation with 3D Roadmap vs. conventional image guidance during trans-arterial embolization procedures.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study start21 Mar 2013
- Primary completion16 Sep 2015
- Study completion22 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Image-Guided SurgeryStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 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 J Wood, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818440
- Sponsor's protocol ID
- 130092
- Other IDs
- 13-CC-0092
- Status last verified
- 22 Aug 2018
- First submitted
- 21 Mar 2013
- Last updated
- 31 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Meyer BC, Witschel M, Frericks BB, Voges M, Hopfenmuller W, Wolf KJ, Wacker FK. The value of combined soft-tissue and vessel visualisation before transarterial chemoembolisation of the liver using C-arm computed tomography. Eur Radiol. 2009 Sep;19(9):2302-9. doi: 10.1007/s00330-009-1410-x. Epub 2009 May 8.
PubMed 19424701Li C, Heidt DG, Dalerba P, Burant CF, Zhang L, Adsay V, Wicha M, Clarke MF, Simeone DM. Identification of pancreatic cancer stem cells. Cancer Res. 2007 Feb 1;67(3):1030-7. doi: 10.1158/0008-5472.CAN-06-2030.
PubMed 17283135Wallace MJ, Murthy R, Kamat PP, Moore T, Rao SH, Ensor J, Gupta S, Ahrar K, Madoff DC, McRae SE, Hicks ME. Impact of C-arm CT on hepatic arterial interventions for hepatic malignancies. J Vasc Interv Radiol. 2007 Dec;18(12):1500-7. doi: 10.1016/j.jvir.2007.07.021.
PubMed 18057284
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial Comparing Navigation With 3D Roadmap vs. Conventional Angiography During Transarterial Embolization
- ClinicalTrials.gov ID
- NCT01818440
- Acronym / sponsor ID
- 130092
- Conditions
- Image-Guided Surgery
- Keywords
- Surgical Navigation, Liver, Cancer, Image-guided Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 21 Mar 2013
- Primary completion
- 16 Sep 2015 (actual)
- Study completion
- 22 Aug 2018 (actual)
- First posted
- 26 Mar 2013 (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.
Background:
- Researchers are interested in comparing two methods that doctors can use to position catheters in blood vessels. These methods are used to deliver chemotherapy and close the blood supply to a tumor. The methods are the standard method called fluoroscopy and a new way called 3-D Roadmap. The 3-D Roadmap software uses computed tomography (CT) images to help the doctor choose the best position for the catheter to get to the tumor. The computer shows the route on an x-ray screen in real time. This technique may help doctors position the catheter with less x-ray dye and in a shorter time. These methods will be compared in people who are having a procedure to destroy liver tumors. The procedure, called trans-arterial embolization, will deliver chemotherapy and destroy the tumor blood supply.
Objectives:
- To compare the effectiveness of fluoroscopy or 3-D Roadmap software for liver tumor treatment.
Eligibility:
- Individuals at least 18 years of age who are having trans-arterial embolization for liver cancer.
Design:
- Participants will be screened with a physical exam and medical history. They will provide blood and urine samples, and have imaging studies.
- Participants will be divided into two groups. One group will have regular fluoroscopy (X-ray) during the procedure. The other group will have the procedure with the 3-D Roadmap software.
- In the first group, participants will have a CT scan. The doctor will decide how many vessels need to be treated. The doctor will advance the catheter using fluoroscopy only. Another CT scan will be given after the procedure.
- In the second group, participants will have a CT scan. The doctor will look at the scan with the 3-D Roadmap software. The software will show the path to advance the catheter. The doctor will use the software to help destroy the tumors. Another CT scan will be given after the procedure.
- Both groups will have the same follow-up care afterward. Other tests will be given as needed for the cancer treatment.
Detailed description
Background:
This is a phase II prospective randomized trial comparing novel tumor segmentation and navigation with 3D roadmap vs. conventional imaging with angiography during trans-arterial embolization procedures. Cone beam CT (CBCT) obtains CT-like images in the angiography suite during trans-arterial chemoembolization procedures and liver chemo-perfusion (PHP). In addition, 2D liver perfusion metrics can be calculated from angiography images. 3D Roadmap is a navigation tool/ software that utilize the data from the CBCT overlaid on live fluoroscopy to display a segmented tumor, delineate its vascular supply and to navigate catheters to the target vessels. Moreover, with 3D Roadmap, CBCT can be fused to prior CT or MRI for improved target visualization. The 3D Roadmap software received 510 (k) clearance on February 19, 2004. Our CRADA partner, Philips Healthcare, also submitted and received a separate 510 (k) clearance on January 30, 2015 for the software s vessel segmentation functionality and is under the trade name Emboguide. 3D Roadmap/ Emboguide software is intended to be used in combination with the AlluraClarity X-ray system.
Primary Objective:
To compare safety, and technical efficiency of navigation with 3D Roadmap vs. conventional image guidance during trans-arterial embolization procedures.
Eligibility:
Subjects are eligible if:
- They are more than 18 years of age
- They have primary or metastatic hepatic tumors scheduled for trans-arterial chemo- embolization or bland embolization in interventional radiology
- They are eligible for trans-arterial chemoembolization or bland embolization
Subjects are excluded if they have:
- An altered mental status precluding understanding or consenting for the procedure
- Contra-indications to trans-arterial embolization
- A gross body weight exceeding 375 pounds (upper limit of angio table)
- A pregnancy
- A severe allergic reaction to iodine contrast which cannot be controlled by premedication with antihistamines and steroids
Design:
- Number of Participants: 30
- Recruitment Time Frame: 2 years
- Number of sites: 1
- Type of Study: prospective randomized clinical trial
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Other: FluoroscopyPatients will have the procedure performed with regular fluoroscopy (X-ray). Regular fluoroscopy is the standard method |
| B | Experimental | Other: 3D Roadmap softwarePatients will have the procedure performed using the 3-D Roadmap software.With the 3DRoadmap, images from a Cone-Beam CT are analyzed. Software shows the vessels supplying the tumor and the plan is displayed on top of fluoroscopy |
Who may qualify
- Ages
- 18 to 99 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 precluding understanding or consenting for the procedure
- History of allergic reactions to iodine contrast, which cannot be controlled by premedication with antihistamines and steroids.
- Pregnant women are excluded from the study because ionizing radiation is teratogenic or abortifacient effects. Patients are excluded from pregnancy testing if they are above the childbearing age of 55 years old, or if they have documented history of infertility or acquired or congenital disorders incompatible with pregnancy or if the patient has had a hysterectomy or bilateral oophorectomy. Patients are also excluded from pregnancy testing if they are at least 50 years of age AND have not menstruated for at least 12 months OR have a documented Follicle Stimulating Hormone (FSH) level of greater than 40 mIU/mL.
- Patients with a total body weight exceeding 375 pounds since that is the weight limit of the angiography table.
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 |
|---|---|---|
| 3D Roadmap softwareTwo scanning methods will be used by doctors to position catheters in the blood vessels to deliver the chemotherapy and close the blood supply to the tumor. | Other | B |
| FluoroscopyPatients will have the procedure performed with regular fluoroscopy (X-ray). Regular fluoroscopy is the standard method. | Other | A |
Primary outcome
To compare safety, efficacy, and technical efficiency of navigation with 3D Roadmap vs. conventional image guidance during trans-arterial embolization procedures.
Time frame: 2 years
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 31 Aug 2018.
- Background: PubMed 19424701Meyer BC, Witschel M, Frericks BB, Voges M, Hopfenmuller W, Wolf KJ, Wacker FK. The value of combined soft-tissue and vessel visualisation before transarterial chemoembolisation of the liver using C-arm computed tomography. Eur Radiol. 2009 Sep;19(9):2302-9. doi: 10.1007/s00330-009-1410-x. Epub 2009 May 8.
- Background: PubMed 17283135Li C, Heidt DG, Dalerba P, Burant CF, Zhang L, Adsay V, Wicha M, Clarke MF, Simeone DM. Identification of pancreatic cancer stem cells. Cancer Res. 2007 Feb 1;67(3):1030-7. doi: 10.1158/0008-5472.CAN-06-2030.
- Background: PubMed 18057284Wallace MJ, Murthy R, Kamat PP, Moore T, Rao SH, Ensor J, Gupta S, Ahrar K, Madoff DC, McRae SE, Hicks ME. Impact of C-arm CT on hepatic arterial interventions for hepatic malignancies. J Vasc Interv Radiol. 2007 Dec;18(12):1500-7. doi: 10.1016/j.jvir.2007.07.021.
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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 J 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 Phase 2 study testing 3D Roadmap software and Fluoroscopy in people with Image-Guided Surgery, 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: finished, as of the sponsor's last update on 31 Aug 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
What does the primary outcome measure?
To compare safety, efficacy, and technical efficiency of navigation with 3D Roadmap vs. conventional image guidance during trans-arterial embolization procedures. (time frame: 2 years). 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 NCT01818440, which also lists 3 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 31 Aug 2018.