Renal Scan in Suspected Obstructive Uropathy in Adult Hydronephrotic PatientNCT04564469
Influence of Diuresis Timing (F+0 Vs F-15) on 99m Tc DTPA Renography for the Diagnosis of Suspected Obstructive Uropathy
An observational study of Renal Scan in Suspected Obstructive Uropathy in Adult Hydronephrotic Patient, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Scan in Suspected Obstructive Uropathy in Adult Hydronephrotic Patient
- What is being tested?
- Furosemide
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to Nov 2021
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: adult patient equal to or more than 18 years old with hydronephrosis and able to be stable on table for 20 minutes not pregnant ,not presented with severe renal impairement\¬ presented with severe hydronephrosis
Who may be able to join
- 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.
Who cannot join
- Severely impaired renal function.
- Advanced hydronephrosis
- Pregnancy.
Trial locations and contacts
No sites are listed yet.
Mohamed Mekkawy contact
About this study
Official title: Influence of Diuresis Timing (F+0 Vs F-15) on 99m Tc DTPA Renography for the Diagnosis of Suspected Obstructive Uropathy in Adult Hydronephrotic Patients.
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.
Read the detailed 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.
- Being tested
- Furosemide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurosemideDrug
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start1 Oct 2020 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Renal Scan in Suspected Obstructive Uropathy in Adult Hydronephrotic PatientStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Gamal Fathy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564469
- Sponsor's protocol ID
- F+0 Vs F-15 in renal scan
- Status last verified
- Sep 2020
- First submitted
- 21 Sep 2020
- Last updated
- 25 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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. No abstract available.
PubMed 29852947Gordon 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.
PubMed 21503762
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Diuresis Timing (F+0 Vs F-15) on 99m Tc DTPA Renography for the Diagnosis of Suspected Obstructive Uropathy in Adult Hydronephrotic Patients.
- ClinicalTrials.gov ID
- NCT04564469
- Acronym / sponsor ID
- F+0 Vs F-15 in renal scan
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 25 Sep 2020 (actual)
- 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.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adult patient equal to or more than 18 years old with hydronephrosis and able to be stable on table for 20 minutes not pregnant ,not presented with severe renal impairement\¬ presented with severe hydronephrosis
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Severely impaired renal function.
- Advanced hydronephrosis
- Pregnancy.
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 |
|---|---|---|
| FurosemideA 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 | Drug | – |
Primary outcome
Comparison between F+0 and F-15 diuretic protocols to differentiate between functional renal obstruction from mechanical obstruction in adult hydronephrotic patients.
Time frame: One year
Analysis of T1/2 in renal scan and find which time of furosemide injection give conclusive results in dignosis of obstructive uropathy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Background: PubMed 29852947Taylor 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. No abstract available.
- Background: PubMed 21503762Gordon 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.
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.
Mohamed Mekkawy contact
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Scan in Suspected Obstructive Uropathy in Adult Hydronephrotic Patient, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact walaa gamal fathy, Resident doctor (01065037395, dr.walaa196@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between F+0 and F-15 diuretic protocols to differentiate between functional renal obstruction from mechanical obstruction in adult hydronephrotic patients. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04564469, which also lists 2 linked publications.
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 25 Sep 2020.