Urinary Tract ObstructionNCT07811388
A Comparative Study of Normalized Residual Activity and Standard Parameters in 99mTc-DTPA Diuretic Renography:
An observational study of Urinary Tract Obstruction, run by Assiut University.
Trial summary
The present study aims to compare the diagnostic performance of Normalized Residual Activity (NORA) with conventional renographic parameters obtained from 99mTc-diethylenetriamine pentaacetic acid (99mTc-DTPA) diuretic renography in the evaluation of patients with suspected urinary tract obstruction. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urinary Tract Obstruction
- What is being tested?
- 99m Tc-DTPA and Furosemide
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- 26 Aug 2026to 1 Aug 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Pediatric or adult patients referred for 99mTc-DTPA diuretic renography because of suspected urinary tract obstruction.
Who may be able to join
- Patients fulfilling all of the following criteria will be eligible for inclusion:
- Pediatric or adult patients referred for 99mTc-DTPA diuretic renography because of suspected urinary tract obstruction.
- Availability of a clinical reference standard (e.g., confirmation of obstruction via surgical findings/pyeloplasty, or proven non-obstruction via stable long-term clinical and radiological follow-up of at least 6-12 months).
Who cannot join
- Patients meeting any of the following criteria will be excluded:
- Patients with severe renal impairment.
- Patients with renal congenital anomalies e.g. horseshoe kidneys
- Technical failure during the scan, including severe patient motion artifacts or failure to properly administer the diuretic
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Improving Obstruction Diagnosis in 99mTc-DTPA Diuretic Renography: A Comparative Study of Normalized Residual Activity and Standard Parameters
The present study aims to compare the diagnostic performance of Normalized Residual Activity (NORA) with conventional renographic parameters obtained from 99mTc-diethylenetriamine pentaacetic acid (99mTc-DTPA) diuretic renography in the evaluation of patients with suspected urinary tract obstruction. The study seeks to determine whether NORA provides superior diagnostic accuracy and specificity for differentiating true urinary tract obstruction from non-obstructive dilatation, thereby improving the interpretation of diuretic renography and supporting appropriate clinical decision-making.
Read the detailed description
Urinary tract obstruction is a common clinical condition encountered in both pediatric and adult populations and represents a significant cause of potentially reversible renal impairment. Persistent obstruction to urinary outflow may result in progressive deterioration of renal function, recurrent urinary tract infections, nephrolithiasis, hypertension, and ultimately irreversible renal damage if diagnosis and appropriate intervention are delayed. Consequently, early identification of clinically significant obstruction is essential to preserve renal function and optimize patient outcomes. However, differentiating true functional obstruction from non-obstructive dilatation remains one of the major diagnostic challenges in daily clinical practice, particularly in patients presenting with hydronephrosis detected by ultrasonography or other anatomical imaging modalities. (1-3) Although ultrasonography, computed tomography (CT), and magnetic resonance urography provide excellent anatomical information regarding the urinary collecting system, they cannot always determine whether dilatation is associated with functionally significant obstruction. Hydronephrosis may occur in the absence of obstruction due to physiological or congenital causes, including an extrarenal pelvis, non-obstructive pelvicalyceal dilatation, vesicoureteral reflux, or postoperative changes. Therefore, anatomical imaging alone is frequently insufficient for determining the need for surgical intervention, emphasizing the importance of functional assessment of urinary drainage. (1-3)
Diuretic renography has become the established functional imaging technique for evaluating suspected urinary tract obstruction. It provides simultaneous assessment of renal perfusion, differential renal function, and urinary drainage after pharmacologically induced diuresis, thereby enabling distinction between obstructive and non-obstructive dilatation. Among the radiopharmaceuticals used in renal scintigraphy, 99mTc-diethylenetriamine pentaacetic acid (99mTc-DTPA) remains widely used because it is eliminated exclusively by glomerular filtration, allowing for the estimation of glomerular filtration rate (GFR) in addition to assessing urinary drainage within a single examination. (1,4)
Interpretation of diuretic renography has traditionally relied on several qualitative and quantitative parameters, including visual assessment of the renogram curve, time to peak activity (Tmax), half-time of tracer clearance (T½), post-diuretic washout, and differential renal function. Although these parameters remain fundamental components of routine clinical practice, each has recognized limitations. Factors such as impaired renal function, severe pelvicalyceal dilatation, inadequate hydration, bladder distension, patient motion, and variations in diuretic administration protocols may significantly influence tracer washout and reduce diagnostic accuracy. Consequently, equivocal or false-positive interpretations may occur, particularly in markedly dilated but non-obstructed collecting systems. (1,4,7)
To overcome these limitations, several alternative quantitative indices have been proposed to improve the assessment of urinary drainage. One of the most promising parameters is Normalized Residual Activity (NORA), which represents the proportion of residual renal tracer activity at a specified time relative to the initial renal uptake. Unlike conventional washout measurements, NORA is less dependent on renal function and collecting system compliance and provides a simple quantitative estimate of residual tracer retention. Previous investigations have demonstrated that NORA improves discrimination between true urinary tract obstruction and non-obstructive dilatation, particularly when measured on post-micturition images. (5-7)
Recent evidence has suggested that NORA demonstrates superior diagnostic specificity compared with conventional renographic interpretation, reducing the number of equivocal examinations and minimizing unnecessary surgical intervention. Beatović et al. reported that post-micturition NORA correctly reclassified the majority of indeterminate or false-positive renographic studies while maintaining excellent diagnostic accuracy for urinary outflow obstruction. Such findings support the incorporation of quantitative drainage parameters into routine renographic interpretation; however, the clinical utility of NORA has not yet been universally adopted and remains insufficiently evaluated across different patient populations and imaging protocols. (5,7)
Given the continuing reliance on conventional renographic parameters in many nuclear medicine departments and the increasing interest in quantitative assessment of renal drainage, further evaluation of NORA is warranted. Comparing NORA with established renographic indices may
provide additional evidence regarding its diagnostic value and its potential role in improving the accuracy of diuretic renography for patients with suspected urinary tract obstruction. Therefore, the present study aims to compare the diagnostic performance of Normalized Residual Activity with conventional renographic parameters in 99mTc-DTPA diuretic renography for the diagnosis of urinary tract obstruction.
Additionally, Cortical Transit Time (CTT) is an effective metric for distinguishing between obstructed and non-obstructed kidneys. A delayed CTT flags kidneys at risk of functional deterioration if surgery is delayed, whereas a normal CTT signals that the kidney is safe from decline, independent of T_(1/2) values or drainage curve patterns. Ultimately, a normal CTT rules out obstruction as effectively as a favorable diuretic renogram drainage pattern [1].
- Conditions
- Urinary Tract Obstruction
- Being tested
- 99m Tc-DTPA, Furosemide
- Keywords
- NORA, Diuretic renography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99m Tc-DTPARadiation
All patients will undergo 99mTc-DTPA diuretic renography according to the standardized departmental protocol.
Patients will receive adequate oral or intravenous hydration before imaging. Following intravenous administration of 99mTc-DTPA, dynamic renal scintigraphy will be performed using a dual-head gamma camera equipped with a low-energy high-resolution collimator.
Furosemide (1" mg/kg" for pediatrics, or a standard 40" mg" dose for adults) will be injected intravenously at 10 minutes post-radiopharmaceutical injection (F+10 protocol) Dynamic imaging will continue for an additional 20minutes.
Patients will be instructed to void at the completion of dynamic imaging after positioning in the upright position for five minutes to promote additional drainage of tracer from the collecting system, followed by acquisition of post-void images.
FurosemideDrug
Furosemide (1 mg/kg for pediatrics, or a standard 40 mg dose for adults) will be injected intravenously at 10 minutes post-radiopharmaceutical injection (F+10 protocol) Dynamic imaging will continue for an additional 20minutes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of Normalized Residual Activity (NORA) Versus conventional renographic parameters in 99mTc-DTPA diuretic renography in the diagnosis of urinary tract obstruction.
Measured: approximately 2 years
Secondary outcomes (3)
• The ability of NORA to differentiate true urinary tract obstruction from non-obstructive urinary tract dilatation.
Measured: approximately 2 years
Clinical usefulness of incorporating NORA into the routine interpretation of 99mTc-DTPA diuretic renography.
Measured: approximately 2 years
The Predictive value of cortical transit time "CTT" for the deterioration in the function of the hydronephrotic kidney.
Measured: approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start26 Aug 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract ObstructionStudies 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
- 57 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahytab Abdelhafez Ezzat Abdelhafez, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811388
- Sponsor's protocol ID
- NORA in diuretic renography
- Status last verified
- Sep 2026
- First submitted
- 30 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Jochumsen MR, Bouchelouche K. PSMA PET/CT for Primary Staging of Prostate Cancer - An Updated Overview. Semin Nucl Med. 2024 Jan;54(1):39-45. doi: 10.1053/j.semnuclmed.2023.07.001. Epub 2023 Jul 22.
PubMed 37487824Farrell MB, Banks KP, Peacock JG. Diuretic Renal Scintigraphy. J Nucl Med Technol. 2022 Dec 7;50(4):319-321. doi: 10.2967/jnmt.122.264804. No abstract available.
PubMed 42619160Taylor 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 29852947Expert Panel on Gastrointestinal Imaging; Bashir MR, Horowitz JM, Kamel IR, Arif-Tiwari H, Asrani SK, Chernyak V, Goldstein A, Grajo JR, Hindman NM, Kamaya A, McNamara MM, Porter KK, Solnes LB, Srivastava PK, Zaheer A, Carucci LR. ACR Appropriateness Criteria(R) Chronic Liver Disease. J Am Coll Radiol. 2020 May;17(5S):S70-S80. doi: 10.1016/j.jacr.2020.01.023.
PubMed 32370979
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Obstruction Diagnosis in 99mTc-DTPA Diuretic Renography: A Comparative Study of Normalized Residual Activity and Standard Parameters
- ClinicalTrials.gov ID
- NCT07811388
- Acronym / sponsor ID
- NORA in diuretic renography
- Conditions
- Urinary Tract Obstruction
- Keywords
- NORA, Diuretic renography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 26 Aug 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 10 Sep 2026 (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.
The present study aims to compare the diagnostic performance of Normalized Residual Activity (NORA) with conventional renographic parameters obtained from 99mTc-diethylenetriamine pentaacetic acid (99mTc-DTPA) diuretic renography in the evaluation of patients with suspected urinary tract obstruction. The study seeks to determine whether NORA provides superior diagnostic accuracy and specificity for differentiating true urinary tract obstruction from non-obstructive dilatation, thereby improving the interpretation of diuretic renography and supporting appropriate clinical decision-making.
Detailed description
Urinary tract obstruction is a common clinical condition encountered in both pediatric and adult populations and represents a significant cause of potentially reversible renal impairment. Persistent obstruction to urinary outflow may result in progressive deterioration of renal function, recurrent urinary tract infections, nephrolithiasis, hypertension, and ultimately irreversible renal damage if diagnosis and appropriate intervention are delayed. Consequently, early identification of clinically significant obstruction is essential to preserve renal function and optimize patient outcomes. However, differentiating true functional obstruction from non-obstructive dilatation remains one of the major diagnostic challenges in daily clinical practice, particularly in patients presenting with hydronephrosis detected by ultrasonography or other anatomical imaging modalities. (1-3) Although ultrasonography, computed tomography (CT), and magnetic resonance urography provide excellent anatomical information regarding the urinary collecting system, they cannot always determine whether dilatation is associated with functionally significant obstruction. Hydronephrosis may occur in the absence of obstruction due to physiological or congenital causes, including an extrarenal pelvis, non-obstructive pelvicalyceal dilatation, vesicoureteral reflux, or postoperative changes. Therefore, anatomical imaging alone is frequently insufficient for determining the need for surgical intervention, emphasizing the importance of functional assessment of urinary drainage. (1-3)
Diuretic renography has become the established functional imaging technique for evaluating suspected urinary tract obstruction. It provides simultaneous assessment of renal perfusion, differential renal function, and urinary drainage after pharmacologically induced diuresis, thereby enabling distinction between obstructive and non-obstructive dilatation. Among the radiopharmaceuticals used in renal scintigraphy, 99mTc-diethylenetriamine pentaacetic acid (99mTc-DTPA) remains widely used because it is eliminated exclusively by glomerular filtration, allowing for the estimation of glomerular filtration rate (GFR) in addition to assessing urinary drainage within a single examination. (1,4)
Interpretation of diuretic renography has traditionally relied on several qualitative and quantitative parameters, including visual assessment of the renogram curve, time to peak activity (Tmax), half-time of tracer clearance (T½), post-diuretic washout, and differential renal function. Although these parameters remain fundamental components of routine clinical practice, each has recognized limitations. Factors such as impaired renal function, severe pelvicalyceal dilatation, inadequate hydration, bladder distension, patient motion, and variations in diuretic administration protocols may significantly influence tracer washout and reduce diagnostic accuracy. Consequently, equivocal or false-positive interpretations may occur, particularly in markedly dilated but non-obstructed collecting systems. (1,4,7)
To overcome these limitations, several alternative quantitative indices have been proposed to improve the assessment of urinary drainage. One of the most promising parameters is Normalized Residual Activity (NORA), which represents the proportion of residual renal tracer activity at a specified time relative to the initial renal uptake. Unlike conventional washout measurements, NORA is less dependent on renal function and collecting system compliance and provides a simple quantitative estimate of residual tracer retention. Previous investigations have demonstrated that NORA improves discrimination between true urinary tract obstruction and non-obstructive dilatation, particularly when measured on post-micturition images. (5-7)
Recent evidence has suggested that NORA demonstrates superior diagnostic specificity compared with conventional renographic interpretation, reducing the number of equivocal examinations and minimizing unnecessary surgical intervention. Beatović et al. reported that post-micturition NORA correctly reclassified the majority of indeterminate or false-positive renographic studies while maintaining excellent diagnostic accuracy for urinary outflow obstruction. Such findings support the incorporation of quantitative drainage parameters into routine renographic interpretation; however, the clinical utility of NORA has not yet been universally adopted and remains insufficiently evaluated across different patient populations and imaging protocols. (5,7)
Given the continuing reliance on conventional renographic parameters in many nuclear medicine departments and the increasing interest in quantitative assessment of renal drainage, further evaluation of NORA is warranted. Comparing NORA with established renographic indices may
provide additional evidence regarding its diagnostic value and its potential role in improving the accuracy of diuretic renography for patients with suspected urinary tract obstruction. Therefore, the present study aims to compare the diagnostic performance of Normalized Residual Activity with conventional renographic parameters in 99mTc-DTPA diuretic renography for the diagnosis of urinary tract obstruction.
Additionally, Cortical Transit Time (CTT) is an effective metric for distinguishing between obstructed and non-obstructed kidneys. A delayed CTT flags kidneys at risk of functional deterioration if surgery is delayed, whereas a normal CTT signals that the kidney is safe from decline, independent of T_(1/2) values or drainage curve patterns. Ultimately, a normal CTT rules out obstruction as effectively as a favorable diuretic renogram drainage pattern [1].
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric or adult patients referred for 99mTc-DTPA diuretic renography because of suspected urinary tract obstruction.
Key inclusion criteria (3 listed)
- Pediatric or adult patients referred for 99mTc-DTPA diuretic renography because of suspected urinary tract obstruction.
- Availability of a clinical reference standard (e.g., confirmation of obstruction via surgical findings/pyeloplasty, or proven non-obstruction via stable long-term clinical and radiological follow-up of at least 6-12 months).
Key exclusion criteria (4 listed)
- Patients with severe renal impairment.
- Patients with renal congenital anomalies e.g. horseshoe kidneys
- Technical failure during the scan, including severe patient motion artifacts or failure to properly administer the diuretic
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 |
|---|---|---|
| 99m Tc-DTPAAll patients will undergo 99mTc-DTPA diuretic renography according to the standardized departmental protocol. Patients will receive adequate oral or intravenous hydration before imaging. Following intravenous administration of 99mTc-DTPA, dynamic renal scintigraphy will be performed using a dual-head gamma camera equipped with a low-energy high-resolution collimator. Furosemide (1" mg/kg" for pediatrics, or a standard 40" mg" dose for adults) will be injected intravenously at 10 minutes post-radiopharmaceutical injection (F+10 protocol) Dynamic imaging will continue for an additional 20minutes. Patients will be instructed to void at the completion of dynamic imaging after positioning in the upright position for five minutes to promote additional drainage of tracer from the collecting system, followed by acquisition of post-void images. | Radiation | – |
| FurosemideFurosemide (1 mg/kg for pediatrics, or a standard 40 mg dose for adults) will be injected intravenously at 10 minutes post-radiopharmaceutical injection (F+10 protocol) Dynamic imaging will continue for an additional 20minutes. | Drug | – |
Primary outcome
Diagnostic performance of Normalized Residual Activity (NORA) Versus conventional renographic parameters in 99mTc-DTPA diuretic renography in the diagnosis of urinary tract obstruction.
Time frame: approximately 2 years
3 secondary outcomes
• The ability of NORA to differentiate true urinary tract obstruction from non-obstructive urinary tract dilatation.
Time frame: approximately 2 years
Clinical usefulness of incorporating NORA into the routine interpretation of 99mTc-DTPA diuretic renography.
Time frame: approximately 2 years
The Predictive value of cortical transit time "CTT" for the deterioration in the function of the hydronephrotic kidney.
Time frame: approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 37487824Jochumsen MR, Bouchelouche K. PSMA PET/CT for Primary Staging of Prostate Cancer - An Updated Overview. Semin Nucl Med. 2024 Jan;54(1):39-45. doi: 10.1053/j.semnuclmed.2023.07.001. Epub 2023 Jul 22.
- Background: PubMed 42619160Farrell MB, Banks KP, Peacock JG. Diuretic Renal Scintigraphy. J Nucl Med Technol. 2022 Dec 7;50(4):319-321. doi: 10.2967/jnmt.122.264804. No abstract available.
- 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 32370979Expert Panel on Gastrointestinal Imaging; Bashir MR, Horowitz JM, Kamel IR, Arif-Tiwari H, Asrani SK, Chernyak V, Goldstein A, Grajo JR, Hindman NM, Kamaya A, McNamara MM, Porter KK, Solnes LB, Srivastava PK, Zaheer A, Carucci LR. ACR Appropriateness Criteria(R) Chronic Liver Disease. J Am Coll Radiol. 2020 May;17(5S):S70-S80. doi: 10.1016/j.jacr.2020.01.023.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Obstruction, 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 4 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: opening soon, as of the sponsor's last update on 10 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahytab Abdelhafez Ezzat, Bachelor (0201096549745, mahytababdelhafezmaster@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of Normalized Residual Activity (NORA) Versus conventional renographic parameters in 99mTc-DTPA diuretic renography in the diagnosis of urinary tract obstruction. (time frame: approximately 2 years). 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 NCT07811388, which also lists 4 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 10 Sep 2026.