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A Comparison of Methods for Assisting Needle Angle Selection During Image-Guided Tissue Biopsy


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Lung Neoplasms, Liver Neoplasms, Kidney Neoplasms, Cancer

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Trial Information

A Comparison of Methods for Assisting Needle Angle Selection During Image-Guided Tissue Biopsy


Background:

- Currently, standard/conventional 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 (e.g. improved diagnostic tissue sampling, decreased

needle repositionings, etc.)

Objectives:

- To compare the angle difference between L-NASS (Method A) and the standard method
(clinician intuition)

- To compare the angle difference between B-NASS (Method B) and the standard method
(clinician intuition)

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(Registered Trademark)
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) 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).

- 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
neither 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.

Inclusion Criteria


- INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

- 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(Registered
Trademark) -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).

- Pregnancy.

- Patients with uncorrectable coagulopathies.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

The angle error (the difference between the planned needle angle and the actual needle angle recorded prior to biopsy procedure).

Principal Investigator

Bradford Wood, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institutes of Health Clinical Center (CC)

Authority:

United States: Federal Government

Study ID:

100217

NCT ID:

NCT01218854

Start Date:

September 2010

Completion Date:

Related Keywords:

  • Lung Neoplasms
  • Liver Neoplasms
  • Kidney Neoplasms
  • Cancer
  • Biopsy
  • Surgical Navigation
  • Image-guided Therapy
  • CT- Guided Biopsy
  • Cancer
  • Neoplasms
  • Kidney Neoplasms
  • Liver Neoplasms
  • Lung Neoplasms

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892