Needle BiopsyNCT00059137
Breathing Cycle Biofeedback During Computed Tomography Procedures
An observational study of Needle Biopsy and CAT Scan, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of a flexible belt device in guiding patient breathing during computed tomography (CT)-guided needle biopsy. When patients undergo CT scanning to help guide the physician during a tissue biopsy, they are usually asked to hold their breath while the scan is taken of certain… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Needle Biopsy, CAT Scan, X-Ray
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Mar 2006
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, 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 have a lesion needing biopsy in the chest or abdominal areas in special procedures requiring CT scan guidance.
- 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.
Who cannot join
- Patients with any of the following will be excluded from study entry:
- Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure will be excluded from this study.
- patients unable to hold breath for more than 5 seconds.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center (CC)
Bethesda, Maryland, 20892
About this study
Official title: Respiratory Cycle Biofeedback During CT Guided Procedures
This study will evaluate the effectiveness of a flexible belt device in guiding patient breathing during computed tomography (CT)-guided needle biopsy. When patients undergo CT scanning to help guide the physician during a tissue biopsy, they are usually asked to hold their breath while the scan is taken of certain parts of the body. When the first scan is completed, the patients are allowed to breathe, and are then asked to hold their breath again while the needle is advanced towards the tissue to be biopsied. Since body organs and tissues move with breathing, this study will try to stop the patient's breathing at the same place in the breathing cycle to ensure that the biopsy target stays still and in the same place. This study will see if the flexible belt, used with a computer screen that charts the patient's breathing, will improve the patient's ability to stop breathing at the same place in the breathing cycle before and during the biopsy.
Patients 18 years of age and older who have a lesion requiring a needle biopsy in the chest or abdominal area may be eligible for this study. The biopsy procedure must require CT scan guidance.
Read more
Participants will undergo the following procedures:
- Breathing exercise: A flexible, loose-fitting belt is placed around the patient's abdomen and the patient is asked to stop breathing in the following ways: 1) take a deep breath in and hold; 2) breathe deeply out and hold; and 3) breathe regularly and hold.
- Needle biopsy: The patient is positioned in a CT scanner and is asked to hold his or her breath while an initial scan is taken. Then the patient is taken out of the scanner and the place the needle entry site for the biopsy is marked on the skin. A local anesthetic is applied to the site and the patient is asked to hold his or her breath the same way as before. During this breath hold, the patient may or may not be shown a computer screen displaying a graph of the patient's breathing and the point in the cycle of the previous breath hold. The biopsy is then performed with CT guidance. While the CT pictures are being taken, the patient is again asked to breathe and hold his or her breath as before. When the biopsy is completed, the belt device is removed.
Read the detailed description
This study will examine the use of a flexible belt placed across the patient's abdomen to sense and plot the patient's respiratory cycle. The point in the respiratory cycle at which the patient holds his/her breath will be recorded at different levels and correlated with CT scans and prior patient breathing levels. Our hypothesis is that a graphical representation of the respiratory cycle may make it easier for the patient to hold his or her breath at the same level each time a CT scan is obtained, or a needle is inserted. If this is true, then this should translate into faster safer procedures, with potentially less ionizing radiation, although this endpoint is not defined in this particular study.
- Conditions
- Needle Biopsy, CAT Scan, X-Ray
- Keywords
- Gating, Respiratory Misregistration, Abdominal Belt, Percutaneous, CT Guided Biopsy, Respiratory Cycle, Needle Biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2003 (estimated)
- Study startApr 2003
- Study completionMar 2006
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 Needle BiopsyStudies 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
- Observational
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00059137
- Sponsor's protocol ID
- 030166
- Other IDs
- 03-CC-0166
- Status last verified
- Mar 2006
- First submitted
- 18 Apr 2003
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Tomiyama N, Mihara N, Maeda M, Johkoh T, Kozuka T, Honda O, Hamada S, Yoshida S, Nakamura H. CT-guided needle biopsy of small pulmonary nodules: value of respiratory gating. Radiology. 2000 Dec;217(3):907-10. doi: 10.1148/radiology.217.3.r00dc10907.
PubMed 11110962Frohlich H, Dohring W. A simple device for breath-level monitoring during CT. Radiology. 1985 Jul;156(1):235. doi: 10.1148/radiology.156.1.4001413.
PubMed 4001413Connolly BL, Chait PG, Duncan DS, Taylor G. CT-guided percutaneous needle biopsy of small lung nodules in children. Pediatr Radiol. 1999 May;29(5):342-6. doi: 10.1007/s002470050603.
PubMed 10382211
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Cycle Biofeedback During CT Guided Procedures
- ClinicalTrials.gov ID
- NCT00059137
- Acronym / sponsor ID
- 030166
- Conditions
- Needle Biopsy, CAT Scan, X-Ray
- Keywords
- Gating, Respiratory Misregistration, Abdominal Belt, Percutaneous, CT Guided Biopsy, Respiratory Cycle, Needle Biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- Apr 2003
- Study completion
- Mar 2006
- First posted
- 18 Apr 2003 (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.
This study will evaluate the effectiveness of a flexible belt device in guiding patient breathing during computed tomography (CT)-guided needle biopsy. When patients undergo CT scanning to help guide the physician during a tissue biopsy, they are usually asked to hold their breath while the scan is taken of certain parts of the body. When the first scan is completed, the patients are allowed to breathe, and are then asked to hold their breath again while the needle is advanced towards the tissue to be biopsied. Since body organs and tissues move with breathing, this study will try to stop the patient's breathing at the same place in the breathing cycle to ensure that the biopsy target stays still and in the same place. This study will see if the flexible belt, used with a computer screen that charts the patient's breathing, will improve the patient's ability to stop breathing at the same place in the breathing cycle before and during the biopsy.
Patients 18 years of age and older who have a lesion requiring a needle biopsy in the chest or abdominal area may be eligible for this study. The biopsy procedure must require CT scan guidance.
Participants will undergo the following procedures:
- Breathing exercise: A flexible, loose-fitting belt is placed around the patient's abdomen and the patient is asked to stop breathing in the following ways: 1) take a deep breath in and hold; 2) breathe deeply out and hold; and 3) breathe regularly and hold.
- Needle biopsy: The patient is positioned in a CT scanner and is asked to hold his or her breath while an initial scan is taken. Then the patient is taken out of the scanner and the place the needle entry site for the biopsy is marked on the skin. A local anesthetic is applied to the site and the patient is asked to hold his or her breath the same way as before. During this breath hold, the patient may or may not be shown a computer screen displaying a graph of the patient's breathing and the point in the cycle of the previous breath hold. The biopsy is then performed with CT guidance. While the CT pictures are being taken, the patient is again asked to breathe and hold his or her breath as before. When the biopsy is completed, the belt device is removed.
Detailed description
This study will examine the use of a flexible belt placed across the patient's abdomen to sense and plot the patient's respiratory cycle. The point in the respiratory cycle at which the patient holds his/her breath will be recorded at different levels and correlated with CT scans and prior patient breathing levels. Our hypothesis is that a graphical representation of the respiratory cycle may make it easier for the patient to hold his or her breath at the same level each time a CT scan is obtained, or a needle is inserted. If this is true, then this should translate into faster safer procedures, with potentially less ionizing radiation, although this endpoint is not defined in this particular study.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- All patients must have a lesion needing biopsy in the chest or abdominal areas in special procedures requiring CT scan guidance.
- 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.
Key exclusion criteria (3 listed)
- Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure will be excluded from this study.
- patients unable to hold breath for more than 5 seconds.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 11110962Tomiyama N, Mihara N, Maeda M, Johkoh T, Kozuka T, Honda O, Hamada S, Yoshida S, Nakamura H. CT-guided needle biopsy of small pulmonary nodules: value of respiratory gating. Radiology. 2000 Dec;217(3):907-10. doi: 10.1148/radiology.217.3.r00dc10907.
- Background: PubMed 4001413Frohlich H, Dohring W. A simple device for breath-level monitoring during CT. Radiology. 1985 Jul;156(1):235. doi: 10.1148/radiology.156.1.4001413.
- Background: PubMed 10382211Connolly BL, Chait PG, Duncan DS, Taylor G. CT-guided percutaneous needle biopsy of small lung nodules in children. Pediatr Radiol. 1999 May;29(5):342-6. doi: 10.1007/s002470050603.
Related trials for Needle Biopsy
RecruitingObservational study
Studies on Tumors of the Thyroid
Hurthle Cell Thyroid Cancer, Tall Cell Variant Thyroid Cancer
RecruitingObservational study
Liquid Biopsy Assay of EBUS-TBNA Supernatant Fluid for Diagnosing Lung Cancer
Non Small Cell Lung Cancer, Non Small Cell Lung Cancer (NSCLC)
RecruitingPhase 2
Effects of Different Fish Oil Types on Type 2 Diabetes Risk Factors in High-Risk Adults
Type 2 Diabetes, Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
RecruitingPhase 4
A Randomized Controlled Trial Comparing Percutaneous CT-Guided Biopsy and Shape-Sensing Robotic-Assisted Bronchoscopy
Lung Cancer (Diagnosis), Lung Nodule
Active, not recruiting
Feasibility and Identification of Breast Cancer Patients for Potential Avoidance of Surgery
Breast Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Needle Biopsy and CAT Scan, 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 5 inclusion and 3 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 4 Mar 2008. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00059137, 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 4 Mar 2008.