Cancer Clinical Trial
Official title:
Prospective Randomized Trial Comparing Navigation With Xperguide vs. Conventional Methods During Percutaneous Image Guided Procedures
Verified date | October 2017 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 87 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
- INCLUSION CRITERIA: 1. they are over 18 years of age 2. they are scheduled for image guided procedure 3. the lesion is not superficial (deeper than 3 cm) EXCLUSION CRITERIA: 1. patients with an altered mental status that precludes understanding or consenting for the procedure 2. patients unable to hold reasonably still on a procedure table for the length of the procedure 3. patient unable to hold their breath if the procedure will be performed with conscious sedation and without general anesthesia 4. patient with a gross body weight over 375 pounds (upper limit of the CT and angiography tables) |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institutes of Health Clinical Center (CC) |
United States,
Abi-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. — View Citation
Carrafiello G, Mangini M, De Bernardi I, Fontana F, Dionigi G, Cuffari S, Imperatori A, Laganà 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. — View Citation
Racadio 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. Review. — View Citation
Spelle 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 hour | |
Primary | Accuracy of Final Device Path (Vector) | Comparing the accuracy of the path the biopsy needle took to get to the site | 1 hour | |
Primary | Radiation Doses Between Xperguide and Conventional CT | Comparing radiation doses to determine if there is a change in the dose between the two interventions | 1 hour | |
Secondary | 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. | 1 hour | |
Secondary | 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. | 1 hour |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05346796 -
Survivorship Plan HEalth REcord (SPHERE) Implementation Trial
|
N/A | |
Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Completed |
NCT04867850 -
Effect of Behavioral Nudges on Serious Illness Conversation Documentation
|
N/A | |
Enrolling by invitation |
NCT04086251 -
Remote Electronic Patient Monitoring in Oncology Patients
|
N/A | |
Completed |
NCT01285037 -
A Study of LY2801653 in Advanced Cancer
|
Phase 1 | |
Completed |
NCT00680992 -
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
|
Phase 2 | |
Completed |
NCT00062842 -
Study of Irinotecan on a Weekly Schedule in Children
|
Phase 1 | |
Active, not recruiting |
NCT04548063 -
Consent Forms in Cancer Research: Examining the Effect of Length on Readability
|
N/A | |
Completed |
NCT04337203 -
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
|
N/A | |
Recruiting |
NCT04349293 -
Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways
|
N/A | |
Terminated |
NCT02866851 -
Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy
|
N/A | |
Active, not recruiting |
NCT05304988 -
Development and Validation of the EFT for Adolescents With Cancer
|
||
Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
Completed |
NCT00340522 -
Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
|
||
Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
Completed |
NCT03109041 -
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
|
Phase 1 | |
Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
Recruiting |
NCT06206785 -
Resting Energy Expenditure in Palliative Cancer Patients
|