CTT on Renogram as an Early Marker of Significant Obstruction in Uretero-pelvic Junction Syndrome (NCT02812212) | Clinical Trial Compass
RecruitingNot Applicable
CTT on Renogram as an Early Marker of Significant Obstruction in Uretero-pelvic Junction Syndrome
France75 participantsStarted 2017-11-28
Plain-language summary
Cortical transit time on diuretic renogram as an early marker of significant obstruction in antenatally detected uretero-pelvic junction syndrome
Who can participate
Age range
4 Weeks – 8 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Infants:
* Aged of 4 to 8 weeks of life
* Presenting an ureteropelvic junction obstruction (UPJO) detected before birth by ultrasound
* Presenting an UPJO, defined by an Antero-Posterior Renal Pelvic Diameter greater or equal to 15 mm, confirmed by ultrasound post-natally between the 1st and 15th day of life
* Presenting a unilateral UPJO
* whose legal representatives have provided a signed free and informed written consent for their infant's participation
* whose at least one of his legal representative is affiliated to national social security
Exclusion Criteria:
Infants presenting:
* A bilateral UPJO
* An ureteral dilatation
* An associated contralateral uropathy
* A solitary kidney
* A renal insufficiency
* Severe associated disabilities ( ie polymalformation syndromes)
* A concomitant participation in another trial
* A contraindication to furosemide (acute renal insufficiency, hepatic encephalopathy, hypovolemia or dehydration, severe hypokalemia, severe hyponatremia)
* A contraindication to the radionuclide marker (hypersensitivity to the active substance or to excipients)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
risk, during the first year of life, of an increase of 4mm or more in the measure of APRPD by ultrasonography as compared to the baseline measure, according to the presence or not of an abnormal cortical transit ti
Timeframe: 3 months, 6 months and 12 months
Trial details
NCT IDNCT02812212
SponsorCentre Hospitalier Universitaire de la Réunion