NephrolithiasisNCT00169780
Kidney Stone Structural Analysis By Helical Computed Tomography (CT)
An observational study of Nephrolithiasis, run by Indiana Kidney Stone Institute at 1 site in United States.
Trial summary
Current practices of the diagnosis of urinary stones gives little information on the probable fragility of stones using shock wave lithotripsy (SWL), and many patients receive more SW's than is necessary to break up their stones. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrolithiasis
- What is being tested?
- High definition helical CT (64 head scanner)
- Type of treatment
- Surgery or procedure
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2002to Aug 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of Methodist Urology, Indianapolis, Indiana who require a CT scan prior to percutaneous removal of renal calculi.
Who may be able to join
- In order to be eligible, patients must meet the following inclusion criteria:
- Male and female kidney stone patients of IU Health Physicians Urology in Indianapolis, IN requiring a computed tomography scan prior to their stone surgical treatment (extracorporeal shock wave lithotripsy [ESWL], percutaneous nephrolithotomy, ureteroscopy)
- Eligible patients must be able to suspend respiration for at least 20 seconds. The patient will be asked to perform a respiration suspension test for 20 seconds before recruitment.
Who cannot join
- Women in whom the potential for pregnancy has not been excluded are not eligible. A pregnancy test will be performed if necessary.
- Inability to give informed consent
- A previous history of abdominal malignancy
Trial locations and contacts
1 site in 1 country.
United States1 site
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Kidney Stone Structural Analysis by Helical Computed Tomography (A Pilot Study)
Current practices of the diagnosis of urinary stones gives little information on the probable fragility of stones using shock wave lithotripsy (SWL), and many patients receive more SW's than is necessary to break up their stones. Indeed, some patients are treated with SWL when their stones cannot be fragmented using this technology. The investigators have ample evidence that computed tomography (CT) images of kidney stones can reveal significant internal structure in stones-structure that is likely to be useful in predicting stone fragility-but no one has explored the use of clinical helical CT for this purpose. Also, the investigators do not know the effect that the human body wall and kidney tissue will have on the resolution of kidney stone structure with helical CT.
Read the detailed description
Helical computed tomography has become the radiologic tool of choice in the assessment and treatment of patients with urinary tract calculi (Hubert et al, 1997; Smith et al, 1999). However, the full potential of helical CT to differentiate among stone types by structure or radiodensity has yet to be realized. Most CT scans for stones are used simply to identify the existence of a stone and give some indication of its size and location. These scans are viewed using soft tissue windows, in order to look for other possible causes of the patient's pain, such as appendicitis, gallstones, and colonic diverticulitis. However, soft tissue windows do not show structure within the kidney stone: stones appear as bright white objects in these images. The potential for observing structure in stones (using viewing windows closer to those used to view bone) has not been assessed in clinical studies. Currently, only the average CT attenuation value of urinary tract calculi has been investigated as an indicator of stone composition (Nakada et al, 2000; Mostafavi et al, 1998; Kuwahara et al, 1984). The average CT attenuation value has been shown to be useful for distinguishing some stones (such as uric acid from calcium oxalate) but considerable overlap in CT attenuation between stone types exist.
Treatment of urinary tract calculi is influenced by many factors including stone location, size and composition. Shock wave lithotripsy (SWL) is an effective, non-invasive method that is utilized to treat the majority of renal calculi. However, while some kidney stones are easily fragmented by SWL, other stones of similar composition are SW-resistant and must be removed by an invasive method following the failed lithotripsy. In addition, SWL is not without complications with long-term risks of hypertension and renal insufficiency (Evan et al, 1998; Willis et al, 1998). Considerable variation in SWL fragility exists within each major stone composition group that is best explained by stone structural heterogeneity (Saw et al, 2000). The association of stone structure and SWL fragility is not a new concept as Dretler and Polykoff (1996), in a retrospective study of calcium oxalate stones, reported four distinct patterns of stone structure on plain abdominal radiographs. Unfortunately, SWL fragility was not directly tested with the authors relying on clinical intuition that stones that on x-ray are smooth and more radiodense (and usually higher calcium oxalate monohydrate content) tend to be harder to fragment with SWL. Finally, the technology for clinical CT continues to advance. The latest generation of multidetector helical CT machines have considerably improved image resolution over single-detector CT technology. These quad-slice scanners have 4 contiguous, parallel rows of x-ray detectors combined with a higher gantry rotation speed which increase the speed of data collection by a factor as high as 8 over the conventional single-slice spiral CT scanners. The evolution from single-slice to multi-slice scanners does not alter image performance in terms of contrast resolution, in-plane spatial resolution and radiation dose if irradiating the same volume. However the benefits of quad-slice spiral CT compared to single-slice spiral CT are significant. The scans may be performed with thinner CT slices, which means higher spatial resolution along the longitudinal axis of the patient. The scans can also be performed much faster, which means improved temporal resolution and less motion artifacts. Thus, the ability to both predict stone composition from kidney stone CT attenuation values and delineate structural features necessary to predict stone fragility to lithotripter shock waves-if not now practical with present technology-will certainly be possible as this technology progresses.
- Conditions
- Nephrolithiasis
- Being tested
- High definition helical CT (64 head scanner)
- Keywords
- Renal Calculi, Radiology, High Reslolution CT
- Medical subject headings
- Nephrolithiasis, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High definition helical CT (64 head scanner)Radiation
Patients who require a CT scan for diagnostic purposes prior to kidney stone surgery will undergo a high definition helical CT rather than the standard CT scan. This high resolution scan will then be reviewed by the researchers to help determine the type of treatment needed for the kidney stone removal. The aim is to see if the higher resolution will show more of the stone "anatomy" which will help the surgeon determine if the stone will be amenable to shock wave lithotripsy or if another type of treatment would best serve the patient needs.
| Study group | Role | What they receive |
|---|---|---|
| cohort | patients who require a CT scan prior to kidney stone surgery for diagnostic purposes Receives: Radiation: High definition helical CT (64 head scanner) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether available clinical helical CT is able to reveal internal structure of kidney stones
Measured: Post op day one
Secondary outcomes (1)
To determine if high resolution CT can differentiate between plaque and renal calculi.
Measured: Post op day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJul 2002
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrolithiasisStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana Kidney Stone Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, National Kidney Foundation, United States
- Responsible party
- Sponsor
- Investigators
- James Lingeman, MD, Principal investigator, IU Health Physicians Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169780
- Sponsor's protocol ID
- 02-035
- Status last verified
- Dec 2011
- First submitted
- 9 Sep 2005
- Last updated
- 7 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kidney Stone Structural Analysis by Helical Computed Tomography (A Pilot Study)
- ClinicalTrials.gov ID
- NCT00169780
- Acronym / sponsor ID
- 02-035
- Conditions
- Nephrolithiasis
- Keywords
- Renal Calculi, Radiology, High Reslolution CT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Indiana Kidney Stone InstituteUniversity, hospital or other
- Collaborators
- Indiana University, National Kidney Foundation, United States
- Study start
- Jul 2002
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 15 Sep 2005 (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.
Current practices of the diagnosis of urinary stones gives little information on the probable fragility of stones using shock wave lithotripsy (SWL), and many patients receive more SW's than is necessary to break up their stones. Indeed, some patients are treated with SWL when their stones cannot be fragmented using this technology. The investigators have ample evidence that computed tomography (CT) images of kidney stones can reveal significant internal structure in stones-structure that is likely to be useful in predicting stone fragility-but no one has explored the use of clinical helical CT for this purpose. Also, the investigators do not know the effect that the human body wall and kidney tissue will have on the resolution of kidney stone structure with helical CT.
Detailed description
Helical computed tomography has become the radiologic tool of choice in the assessment and treatment of patients with urinary tract calculi (Hubert et al, 1997; Smith et al, 1999). However, the full potential of helical CT to differentiate among stone types by structure or radiodensity has yet to be realized. Most CT scans for stones are used simply to identify the existence of a stone and give some indication of its size and location. These scans are viewed using soft tissue windows, in order to look for other possible causes of the patient's pain, such as appendicitis, gallstones, and colonic diverticulitis. However, soft tissue windows do not show structure within the kidney stone: stones appear as bright white objects in these images. The potential for observing structure in stones (using viewing windows closer to those used to view bone) has not been assessed in clinical studies. Currently, only the average CT attenuation value of urinary tract calculi has been investigated as an indicator of stone composition (Nakada et al, 2000; Mostafavi et al, 1998; Kuwahara et al, 1984). The average CT attenuation value has been shown to be useful for distinguishing some stones (such as uric acid from calcium oxalate) but considerable overlap in CT attenuation between stone types exist.
Treatment of urinary tract calculi is influenced by many factors including stone location, size and composition. Shock wave lithotripsy (SWL) is an effective, non-invasive method that is utilized to treat the majority of renal calculi. However, while some kidney stones are easily fragmented by SWL, other stones of similar composition are SW-resistant and must be removed by an invasive method following the failed lithotripsy. In addition, SWL is not without complications with long-term risks of hypertension and renal insufficiency (Evan et al, 1998; Willis et al, 1998). Considerable variation in SWL fragility exists within each major stone composition group that is best explained by stone structural heterogeneity (Saw et al, 2000). The association of stone structure and SWL fragility is not a new concept as Dretler and Polykoff (1996), in a retrospective study of calcium oxalate stones, reported four distinct patterns of stone structure on plain abdominal radiographs. Unfortunately, SWL fragility was not directly tested with the authors relying on clinical intuition that stones that on x-ray are smooth and more radiodense (and usually higher calcium oxalate monohydrate content) tend to be harder to fragment with SWL. Finally, the technology for clinical CT continues to advance. The latest generation of multidetector helical CT machines have considerably improved image resolution over single-detector CT technology. These quad-slice scanners have 4 contiguous, parallel rows of x-ray detectors combined with a higher gantry rotation speed which increase the speed of data collection by a factor as high as 8 over the conventional single-slice spiral CT scanners. The evolution from single-slice to multi-slice scanners does not alter image performance in terms of contrast resolution, in-plane spatial resolution and radiation dose if irradiating the same volume. However the benefits of quad-slice spiral CT compared to single-slice spiral CT are significant. The scans may be performed with thinner CT slices, which means higher spatial resolution along the longitudinal axis of the patient. The scans can also be performed much faster, which means improved temporal resolution and less motion artifacts. Thus, the ability to both predict stone composition from kidney stone CT attenuation values and delineate structural features necessary to predict stone fragility to lithotripter shock waves-if not now practical with present technology-will certainly be possible as this technology progresses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort | – | Radiation: High definition helical CT (64 head scanner)patients who require a CT scan prior to kidney stone surgery for diagnostic purposes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of Methodist Urology, Indianapolis, Indiana who require a CT scan prior to percutaneous removal of renal calculi.
Key inclusion criteria (3 listed)
- Male and female kidney stone patients of IU Health Physicians Urology in Indianapolis, IN requiring a computed tomography scan prior to their stone surgical treatment (extracorporeal shock wave lithotripsy [ESWL], percutaneous nephrolithotomy, ureteroscopy)
- Eligible patients must be able to suspend respiration for at least 20 seconds. The patient will be asked to perform a respiration suspension test for 20 seconds before recruitment.
Key exclusion criteria (3 listed)
- Women in whom the potential for pregnancy has not been excluded are not eligible. A pregnancy test will be performed if necessary.
- Inability to give informed consent
- A previous history of abdominal malignancy
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 |
|---|---|---|
| High definition helical CT (64 head scanner)Patients who require a CT scan for diagnostic purposes prior to kidney stone surgery will undergo a high definition helical CT rather than the standard CT scan. This high resolution scan will then be reviewed by the researchers to help determine the type of treatment needed for the kidney stone removal. The aim is to see if the higher resolution will show more of the stone "anatomy" which will help the surgeon determine if the stone will be amenable to shock wave lithotripsy or if another type of treatment would best serve the patient needs. | Radiation | cohort |
Primary outcome
To determine whether available clinical helical CT is able to reveal internal structure of kidney stones
Time frame: Post op day one
1 secondary outcome
To determine if high resolution CT can differentiate between plaque and renal calculi.
Time frame: Post op day one
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 7 Dec 2011.
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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.
James Lingeman, MD principal investigator
IU Health Physicians Urology
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 Nephrolithiasis, run by Indiana Kidney Stone Institute 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 3 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 7 Dec 2011. 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.
What does the primary outcome measure?
To determine whether available clinical helical CT is able to reveal internal structure of kidney stones (time frame: Post op day one). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Dec 2011.