Living Donor of KidneyDOVISCANNCT02820376
Assessment of Differential Renal Function by CT in Living Donors
A study testing Differential renal function assessment by 4D CT in people with Living Donor of Kidney, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The purpose of this study is to assess the degree of agreement of the measurement of differential renal function in living donors by CT (computed tomography) and SPECT (single photon emission computed tomography). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Living Donor of Kidney
- What is being tested?
- Differential renal function assessment by 4D CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jun 2016to 25 Jun 2018
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Kidney living donor candidate (approval given) undergoing a morphological and functional renal assessment
- Mandatory enrollment in a health security plan (French Social Security)
- Subject having signed an informed consent
Who cannot join
- Contra-indications to computed tomography with iodinated contrast medium injection, or to scintigraphy
- Subjects with an abnormal urinary tract (unique kidney, ectopic kidney, horseshoe kidney)
- Subjets under a legal protection measure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Differential Renal Function by CT in Living Donors - The DOVISCAN Study
The purpose of this study is to assess the degree of agreement of the measurement of differential renal function in living donors by CT (computed tomography) and SPECT (single photon emission computed tomography).
- Conditions
- Living Donor of Kidney
- Being tested
- Differential renal function assessment by 4D CT
- Keywords
- 4D computed tomography, Kidney function tests, Living Donors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Differential renal function assessment by 4D CTOther
Low dose 4D (perfusion) renal acquisition after injection of iodinated contrast medium (ICM) (13 passes every 3 seconds, 3 passes every 10 seconds); estimated additional DLP 400 mGy.cm No additional contrast medium
| Study group | Role | What they receive |
|---|---|---|
| All patients | Other | Differential renal function assessment by 4D CT:
All patients will undergo both CT and SPECT assessment of differential renal function; each patient will be his own comparator Receives: Other: Differential renal function assessment by 4D CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of agreement
Differential renal function (DRF) measured by each technique (CT and SPECT) Regions of interest will be drawn on each kidney and the aorta to obtain time-intensity curves and derive the Patlak plot; the Patlak model will then be used to determine the slope of each kidney and thus to calculate the differential renal function (percentage of each kidney in the total renal function).
Degree of agreement will be assessed by calculating the intra-class correlation coefficient and its 95% confidence interval, and the Bland-Altman plot.
Measured: through study completion (2 years)
Secondary outcomes (4)
Intra- and inter-observer reproducibility of CT DRF measurement
Measured: through study completion (2 years)
Radiation dose exposure for each technique
Additional radiation dose exposure (CTDIvol and DLP) will be recorded and follow-up
Measured: 1 day
Agreement between post-processing methods for CT
Comparison between Patlak-Ruthland method, its modified version and the area under the curve method
Measured: through study completion (2 years)
Automatic post-processing for Patlak-Ruthland method
Measured: through study completion (2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study start28 Jun 2016
- Primary completion25 Jun 2018
- Study completion25 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Living Donor of KidneyStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, University of Lorraine
- Responsible party
- Sponsor
- Investigators
- Damien Mandry, MD,PhD, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820376
- Sponsor's protocol ID
- 2016-A00543-48
- Other IDs
- PSS 2016 / DOVISCAN - MANDRY /
- Acronym
- DOVISCAN
- Status last verified
- May 2020
- First submitted
- 20 Jun 2016
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Differential Renal Function by CT in Living Donors - The DOVISCAN Study
- ClinicalTrials.gov ID
- NCT02820376
- Acronym / sponsor ID
- DOVISCAN / 2016-A00543-48
- Conditions
- Living Donor of Kidney
- Keywords
- 4D computed tomography, Kidney function tests, Living Donors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, University of Lorraine
- Study start
- 28 Jun 2016 (actual)
- Primary completion
- 25 Jun 2018 (actual)
- Study completion
- 25 Jun 2018 (actual)
- First posted
- 1 Jul 2016 (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.
The purpose of this study is to assess the degree of agreement of the measurement of differential renal function in living donors by CT (computed tomography) and SPECT (single photon emission computed tomography).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Other | Other: Differential renal function assessment by 4D CTDifferential renal function assessment by 4D CT: All patients will undergo both CT and SPECT assessment of differential renal function; each patient will be his own comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Kidney living donor candidate (approval given) undergoing a morphological and functional renal assessment
- Mandatory enrollment in a health security plan (French Social Security)
- Subject having signed an informed consent
Key exclusion criteria (3 listed)
- Contra-indications to computed tomography with iodinated contrast medium injection, or to scintigraphy
- Subjects with an abnormal urinary tract (unique kidney, ectopic kidney, horseshoe kidney)
- Subjets under a legal protection measure
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 |
|---|---|---|
| Differential renal function assessment by 4D CTLow dose 4D (perfusion) renal acquisition after injection of iodinated contrast medium (ICM) (13 passes every 3 seconds, 3 passes every 10 seconds); estimated additional DLP 400 mGy.cm No additional contrast medium | Other | All patients |
Primary outcome
degree of agreement
Time frame: through study completion (2 years)
Differential renal function (DRF) measured by each technique (CT and SPECT) Regions of interest will be drawn on each kidney and the aorta to obtain time-intensity curves and derive the Patlak plot; the Patlak model will then be used to determine the slope of each kidney and thus to calculate the differential renal function (percentage of each kidney in the total renal function). Degree of agreement will be assessed by calculating the intra-class correlation coefficient and its 95% confidence interval, and the Bland-Altman plot.
4 secondary outcomes
Intra- and inter-observer reproducibility of CT DRF measurement
Time frame: through study completion (2 years)
Radiation dose exposure for each technique
Time frame: 1 day
Agreement between post-processing methods for CT
Time frame: through study completion (2 years)
Automatic post-processing for Patlak-Ruthland method
Time frame: through study completion (2 years)
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 8 May 2020.
- Individual participant dataSharing planned: No
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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.
Damien Mandry, MD,PhD principal investigator
CHRU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Differential renal function assessment by 4D CT in people with Living Donor of Kidney, run by Central Hospital, Nancy, France at 1 site in France.
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 8 May 2020. 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 France. 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?
degree of agreement (time frame: through study completion (2 years)). 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 8 May 2020.