Ignite Creation Date:
2024-05-05 @ 10:56 PM
Last Modification Date:
2024-10-26 @ 10:26 AM
Study NCT ID:
NCT01218854
Status:
COMPLETED
Last Update Posted:
2024-06-28
First Post:
2010-10-08
Brief Title:
A Comparison of Methods for Assisting Needle Angle Selection During Image-guided Tissue Biopsy
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Comparison of Methods for Assisting Needle Angle Selection During Image-Guided Tissue Biopsy
Status:
COMPLETED
Status Verified Date:
2024-05-28
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
- Currently standard procedures for biopsies that are guided by computed tomography CT imaging involve CT scans and a computer program to plan and illustrate where the physician will place the needle to obtain the required cells or tissue Inserting the biopsy needle at the planned angle is not an easy task because the appropriate angle of insertion must be estimated based on prior experience Researchers are studying experimental techniques that might provide better guidance about the right angle to insert the biopsy needle and thereby improve the collection of the appropriate biopsy cells or tissue
Objectives
- To evaluate the effectiveness of two biopsy needle guidance methods in CT-guided tissue biopsy
Eligibility
- Individuals at least 18 years of age who are scheduled to have CT-guided tissue biopsy
Design
Participants will have a tissue biopsy guided by CT scans and either a laser system or a plastic block to illustrate the appropriate angle of insertion The skin will be numbed with anesthetic to minimize discomfort during the procedure
Before inserting the biopsy needle the study physician will hold the needle in place so that a Food and Drug Administration-approved medical GPS electromagnetic tracking system can measure the needle angle as it enters the tissue
After the needle angle data has been collected researchers will proceed with the actual biopsy procedure as it would normally occur using standard methods
No additional treatment will be provided as part of this protocol
- Currently standard procedures for biopsies that are guided by computed tomography CT imaging involve CT scans and a computer program to plan and illustrate where the physician will place the needle to obtain the required cells or tissue Inserting the biopsy needle at the planned angle is not an easy task because the appropriate angle of insertion must be estimated based on prior experience Researchers are studying experimental techniques that might provide better guidance about the right angle to insert the biopsy needle and thereby improve the collection of the appropriate biopsy cells or tissue
Objectives
- To evaluate the effectiveness of two biopsy needle guidance methods in CT-guided tissue biopsy
Eligibility
- Individuals at least 18 years of age who are scheduled to have CT-guided tissue biopsy
Design
Participants will have a tissue biopsy guided by CT scans and either a laser system or a plastic block to illustrate the appropriate angle of insertion The skin will be numbed with anesthetic to minimize discomfort during the procedure
Before inserting the biopsy needle the study physician will hold the needle in place so that a Food and Drug Administration-approved medical GPS electromagnetic tracking system can measure the needle angle as it enters the tissue
After the needle angle data has been collected researchers will proceed with the actual biopsy procedure as it would normally occur using standard methods
No additional treatment will be provided as part of this protocol
Detailed Description:
Background
Currently standardconventional CT-guided biopsies proceed as follows the physician
1 obtains a pre-procedural CT scan
2 plans the needle s angle based on this CT scan
3 selects the angle at which the needle should be inserted based on the pre-procedural CT scan
4 inserts the needle while aiming to replicate that planned needle angle by using only their visual-spatial abilities and
5 re-images the patient to confirm needle location followed by needle
repositioning if needed
Improving upon these standard methods of needle placement could have
widespread benefits eg improved diagnostic tissue sampling decreased
needle repositionings etc We will be studying three needle angle selection systems The laser-assisted needle angle selection system or LNASS is a custom fabricated device that uses a Class II pointer similar to ones used for pointing at slides during lectures
Objectives
To compare the angle difference between L-NASS Method A and the standard method clinician intuitionconventional method
To compare the angle difference between B-NASS Method B and the standard method clinician intuition
To compare the angle difference between the mobile device-NASS or MD-NASS C and the standard method clinician intuitionconventional method
Eligibility
Ages Eligible for Study 18 Years and older
Genders Eligible for Study Both
Inclusion
Must be undergoing a scheduled CT-guided biopsy
Must have ability to follow breathing instructions like holding breath if procedure is to be performed without general anesthesia
Exclusion
No serious concurrent medical illness that would preclude the patient from making a rational informed decision on participation
Any known allergy to plastics or polymers since the Ultem polymer could theoretically induce a rash in these patients even though it is hypoallergenic
Pacemakers or automatic implantable cardiac defibrillators
Gross body weight above the CT table limit 450 pounds
Design
Primary outcome measure for the first arm is
--The difference between planned and achieved needle angle of a laser-assisted needle angle selection system with the standard method clinician s intuition or conventional method of CT-guided biopsy
Primary outcome measure for the second arm is
--The difference between planned and achieved needle angle of a block with pre-drilled needle angles with the standard method clinician s intuition or conventional method of CT-guided biopsy
Primary outcome for the third arm is
--The difference between planned and achieved needle angle of a mobile device-assisted needle angle selection system with the standard method clinicians intuition or conventional method of CT-guided biopsy
The tool for measuring the needle angles will be an FDA-approved electromagnetic tracking system which tracks needle movement and position
These comparisons will be done as a bystander study
Needle guidance system will only be used initially to select the angle during a superficial shallow needle insertion at the skin surface less than 1 cm deep
At no time will the needle enter tissue that it wouldn t have otherwise entered as none of the system will be used to perform the biopsies at this time
The key portions of the procedure will not be altered in any substantive way
Currently standardconventional CT-guided biopsies proceed as follows the physician
1 obtains a pre-procedural CT scan
2 plans the needle s angle based on this CT scan
3 selects the angle at which the needle should be inserted based on the pre-procedural CT scan
4 inserts the needle while aiming to replicate that planned needle angle by using only their visual-spatial abilities and
5 re-images the patient to confirm needle location followed by needle
repositioning if needed
Improving upon these standard methods of needle placement could have
widespread benefits eg improved diagnostic tissue sampling decreased
needle repositionings etc We will be studying three needle angle selection systems The laser-assisted needle angle selection system or LNASS is a custom fabricated device that uses a Class II pointer similar to ones used for pointing at slides during lectures
Objectives
To compare the angle difference between L-NASS Method A and the standard method clinician intuitionconventional method
To compare the angle difference between B-NASS Method B and the standard method clinician intuition
To compare the angle difference between the mobile device-NASS or MD-NASS C and the standard method clinician intuitionconventional method
Eligibility
Ages Eligible for Study 18 Years and older
Genders Eligible for Study Both
Inclusion
Must be undergoing a scheduled CT-guided biopsy
Must have ability to follow breathing instructions like holding breath if procedure is to be performed without general anesthesia
Exclusion
No serious concurrent medical illness that would preclude the patient from making a rational informed decision on participation
Any known allergy to plastics or polymers since the Ultem polymer could theoretically induce a rash in these patients even though it is hypoallergenic
Pacemakers or automatic implantable cardiac defibrillators
Gross body weight above the CT table limit 450 pounds
Design
Primary outcome measure for the first arm is
--The difference between planned and achieved needle angle of a laser-assisted needle angle selection system with the standard method clinician s intuition or conventional method of CT-guided biopsy
Primary outcome measure for the second arm is
--The difference between planned and achieved needle angle of a block with pre-drilled needle angles with the standard method clinician s intuition or conventional method of CT-guided biopsy
Primary outcome for the third arm is
--The difference between planned and achieved needle angle of a mobile device-assisted needle angle selection system with the standard method clinicians intuition or conventional method of CT-guided biopsy
The tool for measuring the needle angles will be an FDA-approved electromagnetic tracking system which tracks needle movement and position
These comparisons will be done as a bystander study
Needle guidance system will only be used initially to select the angle during a superficial shallow needle insertion at the skin surface less than 1 cm deep
At no time will the needle enter tissue that it wouldn t have otherwise entered as none of the system will be used to perform the biopsies at this time
The key portions of the procedure will not be altered in any substantive way
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10-CC-0217 | None | None | None |