Lung NeoplasmsPhase 1NCT01218854
A Comparison of Methods for Assisting Needle Angle Selection During Image-guided Tissue Biopsy
A Phase 1 study testing Needle angle measurement in people with Lung Neoplasms and Liver Neoplasms, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms, Liver Neoplasms, Kidney Neoplasms
- What is being tested?
- Needle angle measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2012to 16 Nov 2016
- Phase
- Phase 1
- 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
Who may be able to join
- Patients must fulfill all of the following criteria to be eligible for study admission:
- All patients must be undergoing a CT-guided biopsy.
- Age greater than 18 years.
- No serious concurrent medical illness that would preclude the patient from making a rational informed decision on participation.
- The ability to understand and willingness to sign a written informed consent form, and to comply with the protocol. If in question, an ethics consult will be obtained.
- Ability to follow breathing instructions like holding breath (if procedure is to be performed without general anesthesia).
- Patients must be actively enrolled on an NIH protocol and be scheduled for a CT-guided biopsy.
Who cannot join
- Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure will be excluded from this study.
- Patients unlikely to be able to hold reasonably still on a procedure table for the length of the procedure.
- Patients with any known allergy to plastics or polymers (since the Ultem -polymer could theoretically induce a rash in these patients, even though it is hypoallergenic).
- Inability to follow breathing instructions, if without general anesthesia.
- Patients with pacemakers or automatic implantable cardiac defibrillators.
- Gross body weight above the CT table limit (450 pounds).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: A Comparison of Methods for Assisting Needle Angle Selection During Image-Guided Tissue Biopsy
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.
Read more
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.
Read the detailed description
Background:
- Currently, standard/conventional CT-guided biopsies proceed as follows the physician:
- obtains a pre-procedural CT scan,
- plans the needle s angle based on this CT scan,
- selects the angle at which the needle should be inserted based on the pre-procedural CT scan,
- inserts the needle while aiming to replicate that planned needle angle by using only their visual-spatial abilities, and
- 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 (e.g. 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 intuition/conventional 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 intuition/conventional 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 (clinician's 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.
- Conditions
- Lung Neoplasms, Liver Neoplasms, Kidney Neoplasms, Cancer
- Being tested
- Needle angle measurement
- Keywords
- Biopsy, Surgical Navigation, Image-guided Therapy, CT- Guided Biopsy, Cancer
- Medical subject headings
- Lung Neoplasms, Liver Neoplasms, Kidney Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needle angle measurementDevice
The tool for measuring the needle angles will be an FDA-approved EM tracking system. At no time will the needle enter tissue that it wouldn t have otherwise entered as neither system will be used to perform the biopsies at this time.
| Study group | Role | What they receive |
|---|---|---|
| B-NASS | Experimental | Block assisted needle angle selection system Receives: Device: Needle angle measurement |
| L-NASS | Experimental | laser assisted needle angle selection system Receives: Device: Needle angle measurement |
| MD-NASS | Experimental | mobile-device assisted needle angle selection system Receives: Device: Needle angle measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between L-NASS and standard method
Data is currently undergoing analysis
Measured: Completion of study
Differnce between B-NASS and standard method
Data is currently undergoing analysis
Measured: Completion of study
The difference between MD-NASS and standard method
Data is currently undergoing analysis
Measured: Completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study start20 Mar 2012
- Primary completion16 Nov 2016
- Study completion16 Nov 2016
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 Lung NeoplasmsStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 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
- NCT01218854
- Sponsor's protocol ID
- 100217
- Other IDs
- 10-CC-0217
- Status last verified
- Sep 2025
- First submitted
- 8 Oct 2010
- Last updated
- 22 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available and still undecided.
Publications
Miaux Y, Guermazi A, Gossot D, Bourrier P, Angoulvant D, Khairoune A, Turki C, Bouche E. Laser guidance system for CT-guided procedures. Radiology. 1995 Jan;194(1):282-4. doi: 10.1148/radiology.194.1.7997570.
PubMed 7997570Pereles FS, Baker M, Baldwin R, Krupinski E, Unger EC. Accuracy of CT biopsy: laser guidance versus conventional freehand techniques. Acad Radiol. 1998 Nov;5(11):766-70. doi: 10.1016/s1076-6332(98)80260-2.
PubMed 9809074Jacobi V, Thalhammer A, Kirchner J. Value of a laser guidance system for CT interventions: a phantom study. Eur Radiol. 1999;9(1):137-40. doi: 10.1007/s003300050644.
PubMed 9933397
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Methods for Assisting Needle Angle Selection During Image-Guided Tissue Biopsy
- ClinicalTrials.gov ID
- NCT01218854
- Acronym / sponsor ID
- 100217
- Conditions
- Lung Neoplasms, Liver Neoplasms, Kidney Neoplasms, Cancer
- Keywords
- Biopsy, Surgical Navigation, Image-guided Therapy, CT- Guided Biopsy, Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 20 Mar 2012 (actual)
- Primary completion
- 16 Nov 2016 (actual)
- Study completion
- 16 Nov 2016 (actual)
- First posted
- 11 Oct 2010 (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:
- 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, standard/conventional CT-guided biopsies proceed as follows the physician:
- obtains a pre-procedural CT scan,
- plans the needle s angle based on this CT scan,
- selects the angle at which the needle should be inserted based on the pre-procedural CT scan,
- inserts the needle while aiming to replicate that planned needle angle by using only their visual-spatial abilities, and
- 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 (e.g. 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 intuition/conventional 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 intuition/conventional 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 (clinician's 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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| B-NASS | Experimental | Device: Needle angle measurementBlock assisted needle angle selection system |
| L-NASS | Experimental | Device: Needle angle measurementlaser assisted needle angle selection system |
| MD-NASS | Experimental | Device: Needle angle measurementmobile-device assisted needle angle selection system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All patients must be undergoing a CT-guided biopsy.
- Age greater than 18 years.
- No serious concurrent medical illness that would preclude the patient from making a rational informed decision on participation.
- The ability to understand and willingness to sign a written informed consent form, and to comply with the protocol. If in question, an ethics consult will be obtained.
- Ability to follow breathing instructions like holding breath (if procedure is to be performed without general anesthesia).
Key exclusion criteria (6 listed)
- Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure will be excluded from this study.
- Patients unlikely to be able to hold reasonably still on a procedure table for the length of the procedure.
- Patients with any known allergy to plastics or polymers (since the Ultem -polymer could theoretically induce a rash in these patients, even though it is hypoallergenic).
- Inability to follow breathing instructions, if without general anesthesia.
- Patients with pacemakers or automatic implantable cardiac defibrillators.
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 |
|---|---|---|
| Needle angle measurementThe tool for measuring the needle angles will be an FDA-approved EM tracking system. At no time will the needle enter tissue that it wouldn t have otherwise entered as neither system will be used to perform the biopsies at this time. | Device | B-NASS, L-NASS, MD-NASS |
Primary outcome
Difference between L-NASS and standard method
Time frame: Completion of study
Data is currently undergoing analysis
Differnce between B-NASS and standard method
Time frame: Completion of study
Data is currently undergoing analysis
The difference between MD-NASS and standard method
Time frame: Completion of study
Data is currently undergoing analysis
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 22 Sep 2025.
- Background: PubMed 7997570Miaux Y, Guermazi A, Gossot D, Bourrier P, Angoulvant D, Khairoune A, Turki C, Bouche E. Laser guidance system for CT-guided procedures. Radiology. 1995 Jan;194(1):282-4. doi: 10.1148/radiology.194.1.7997570.
- Background: PubMed 9809074Pereles FS, Baker M, Baldwin R, Krupinski E, Unger EC. Accuracy of CT biopsy: laser guidance versus conventional freehand techniques. Acad Radiol. 1998 Nov;5(11):766-70. doi: 10.1016/s1076-6332(98)80260-2.
- Background: PubMed 9933397Jacobi V, Thalhammer A, Kirchner J. Value of a laser guidance system for CT interventions: a phantom study. Eur Radiol. 1999;9(1):137-40. doi: 10.1007/s003300050644.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available and still undecided.
Related trials for Lung Neoplasms
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
RecruitingObservational study
Cancer Experience Registry (CER) for Cancer Patients and Caregivers
Neoplasms, Cancer
Active, not recruiting
Pilot Study of SGRT Alone vs. SGRT With Fiducials for Breath Hold SBRT tx of the Lung
Lung Cancer
RecruitingPhase 1/2
KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
Carcinoma, Non-Small-Cell Lung
RecruitingObservational study
KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)
Carcinoma, Non-Small-Cell Lung
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 1 study testing Needle angle measurement in people with Lung Neoplasms and Liver Neoplasms, 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 7 inclusion and 6 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 22 Sep 2025. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Difference between L-NASS and standard method (time frame: Completion of study). 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 NCT01218854, 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 22 Sep 2025; AzTrials last refreshed its copy on 30 Oct 2026.