Actively Recruiting

Phase Not Applicable
Age: 4Weeks - 8Weeks
All Genders
ID02812212

Cortical Transit Time on Diuretic Renogram as an Early Marker of Significant Obstruction in Antenatally Detected Uretero-pelvic Junction Syndrome

Led by Centre Hospitalier Universitaire de la Réunion · Updated on 2022-09-29

75

Participants Needed

5

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying ureteropelvic junction obstruction (UPJO) detected before birth, a condition where urine flow from the kidney is blocked, which can cause kidney damage if untreated. This study aims to find early markers of significant obstruction to better decide when surgery is needed. Currently, doctors use diuretic renography and ultrasound, but these methods often detect problems only after kidney damage begins. The study focuses on measuring cortical transit time (CTT) and positional changes in kidney measurements as potential early indicators. Participants will undergo bilateral ultrasonography to measure the antero-posterior renal pelvic diameter (APRPD) in different positions and diuretic renography to measure cortical transit time. These non-invasive imaging tests will be performed at specified intervals to assess kidney function and obstruction severity. The study will compare these two markers to evaluate their ability to predict worsening obstruction. Families of infants aged 4 to 8 weeks with a confirmed unilateral UPJO will be involved. Researchers will monitor changes in APRPD through ultrasound at 3, 6, and 12 months, focusing on whether an increase of 4 mm or more occurs in the first year. The study includes regular imaging and clinical assessments, with the goal to improve early diagnosis and management decisions, reducing unnecessary surgeries and better protecting kidney health.

CONDITIONS

Brief Title

CTT on Renogram as an Early Marker of Significant Obstruction in Uretero-pelvic Junction Syndrome

Who Can Participate

Age: 4Weeks - 8Weeks
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants aged 4 to 8 weeks
  • Ureteropelvic junction obstruction detected before birth by ultrasound
  • Antero-posterior renal pelvic diameter (APRPD) of 15 mm or more confirmed by ultrasound between days 1 and 15 after birth
  • Unilateral ureteropelvic junction obstruction
  • Signed informed consent from legal representatives
  • At least one legal representative affiliated with national social security
Not Eligible

You will not qualify if you...

  • Bilateral ureteropelvic junction obstruction
  • Ureteral dilatation
  • Contralateral uropathy
  • Solitary kidney
  • Renal insufficiency
  • Severe disabilities such as polymalformation syndromes
  • Participation in another clinical trial
  • Contraindications to furosemide (e.g., acute renal insufficiency, hepatic encephalopathy, hypovolemia, dehydration, severe hypokalemia, severe hyponatremia)
  • Contraindications to radionuclide marker (hypersensitivity to active substance or excipients)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 12 months

Participants undergo bilateral ultrasonography to measure the antero-posterior renal pelvic diameter (APRPD) in different positions and diuretic renography to measure cortical transit time as early markers of obstruction.

Visits at 3 months, 6 months, and 12 months

Long-term Monitoring

Duration - Up to 12 months

Participants are monitored during the first year of life to assess changes in APRPD and renal function based on diagnostic evaluations.

Follow-up visits at 3, 6, and 12 months post-baseline

Trial Site Locations

Total: 5 locations

1

CHU de Bordeaux

Bordeaux, France, 33076

Actively Recruiting

2

CHU de Limoges

Limoges, France, 87000

Actively Recruiting

3

CHU de Nantes

Nantes, France, 44000

Not Yet Recruiting

4

CHU de Rennes

Rennes, France, 35023

Not Yet Recruiting

5

Centre Hospitalier Universitaire de La Réunion

Saint-Denis, France, 97400

Actively Recruiting

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Research Team

L

Lucie Auzanneau

V

Valérie Fontaine

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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