NIH Clinical Center Search the Studies: Study Number, Study Title

Protocol Details

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

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

10-CC-0217

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

Children

Keywords

Biopsy;
Surgical Navigation;
Image-guided Therapy

Recruitment Keyword(s)

Biopsy;
CT- Guided Biopsy;
Cancer

Condition(s)

Lung Neoplasms;
Liver Neoplasms;
Kidney Neoplasms;
Cancer

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Device: Needle angle measurement

Supporting Site

NIH Clinical Center

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.

--Back to Top--

Eligibility

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 -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).


--Back to Top--

Citations:

Miaux Y, Guermazi A, Gossot D, Bourrier P, Angoulvant D, Khairoune A, Turki C, Bouch(SqrRoot)(Copyright) E. Laser guidance system for CT- guided procedures. Radiology. 1995 Jan;194(1):282-4.

Pereles 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.

Jacobi V, Thalhammer A, Kirchner J. Value of a laser guidance system for CT interventions: a phantom study. Eur Radiol. 1999;9(1):137-40.

--Back to Top--

Contacts:

Principal Investigator

Referral Contact

For more information:

Bradford J. Wood, M.D.
National Institutes of Health Clinical Center (CC)
NIHBC 10 - CLINICAL CENTER BG RM 1C341
10 CENTER DR
BETHESDA MD 20892
(301) 496-7739
bwood@mail.cc.nih.gov

Charisse Garcia, R.N.
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 1C364
10 Center Drive
Bethesda, Maryland 20892
(301) 594-4511
garciacr@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT01218854

--Back to Top--