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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04564469
Other study ID # F+0 Vs F-15 in renal scan
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date November 2021

Study information

Verified date September 2020
Source Assiut University
Contact walaa gamal fathy, Resident doctor
Phone 01065037395
Email dr.walaa196@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Evaluation of the influence of the diuretic injection timing (F+0 Vs F-15) on the dynamic 99mTc- DTPA renal scintigraphy for the diagnosis of suspected obstructive uropathy in adult hydronephrotic patients.


Description:

Obstructive uropathy can be defined as any blockage of urine drainage from the kidney (renal calyces or renal pelvis), ureter, or bladder. As a result of the blockage, urine backs up into the kidneys, causing dilatation of the ureter, renal pelvis, and renal calyces, which can damage the kidney if it is not treated. The appearance of dilated or enlarged renal pelvis and calyces is referred to as hydronephrosis and is a symptom of obstructive uropathy.

Diuresis renography(renal scan with using of diuretic drug such as furosemide) is non-invasive test which is based on a high endogenous rate of urine flow stimulated by the administration of furosemide. Interpretation of the test is based on the rate of washout of the radiopharmaceutical from the collecting system in the upper urinary tract.

A number of different protocols exist in terms of the timing of furosemide injection, (F+0) protocol in which furosemide is injected at the same time of radiotracer administration &( F - 15)protocol in which furosemide is administered 15 min before tracer administration.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date November 2021
Est. primary completion date November 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Adult patients = 18 years.

- Patients with hydronephrosis (unilateral or bilateral) referred for renal scan.

- Patients able to sleep in a fixed position for 20 minutes.

Exclusion Criteria:

- Severely impaired renal function.

- Advanced hydronephrosis

- Pregnancy.

Study Design


Related Conditions & MeSH terms

  • Renal Scan in Suspected Obstructive Uropathy in Adult Hydronephrotic Patient
  • Urologic Diseases

Intervention

Drug:
Furosemide
A number of different protocols exist in terms of the timing of furosemide injection, (F+0) protocol in which furosemide is injected at the same time of radiotracer administration &( F - 15)protocol in which furosemide is administered 15 min before tracer administration

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (2)

Gordon I, Piepsz A, Sixt R; Auspices of Paediatric Committee of European Association of Nuclear Medicine. Guidelines for standard and diuretic renogram in children. Eur J Nucl Med Mol Imaging. 2011 Jun;38(6):1175-88. doi: 10.1007/s00259-011-1811-3. — View Citation

Taylor AT, Brandon DC, de Palma D, Blaufox MD, Durand E, Erbas B, Grant SF, Hilson AJW, Morsing A. SNMMI Procedure Standard/EANM Practice Guideline for Diuretic Renal Scintigraphy in Adults With Suspected Upper Urinary Tract Obstruction 1.0. Semin Nucl Med. 2018 Jul;48(4):377-390. doi: 10.1053/j.semnuclmed.2018.02.010. Epub 2018 Mar 16. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison between F+0 and F-15 diuretic protocols to differentiate between functional renal obstruction from mechanical obstruction in adult hydronephrotic patients. Analysis of T1/2 in renal scan and find which time of furosemide injection give conclusive results in dignosis of obstructive uropathy One year