A Comparative Study of Normalized Residual Activity and Standard Parameters in 99mTc-DTPA Diuretic Renography:

NCT07811388 | Not Yet Recruiting FDA Drug FDA Device

• 1 other identifier: NORA in diuretic renography
• Study Type: observational
• Target: 57
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Urinary Tract Obstruction

Keywords

NORA; Diuretic renography

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of Normalized Residual Activity (NORA) Versus conventional renographic parameters in 99mTc-DTPA diuretic renography in the diagnosis of urinary tract obstruction.

  approximately 2 years

Secondary Outcomes (3)

• • The ability of NORA to differentiate true urinary tract obstruction from non-obstructive urinary tract dilatation.

  approximately 2 years

• Clinical usefulness of incorporating NORA into the routine interpretation of 99mTc-DTPA diuretic renography.

  approximately 2 years

• The Predictive value of cortical transit time "CTT" for the deterioration in the function of the hydronephrotic kidney.

  approximately 2 years

Interventions

99m Tc-DTPA RADIATION

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.

Furosemide DRUG

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.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric or adult patients referred for 99mTc-DTPA diuretic renography because of suspected urinary tract obstruction.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• 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.

  PMID: 37487824 BACKGROUND

• Farrell 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.

  PMID: 42619160 BACKGROUND

• 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.

  PMID: 29852947 BACKGROUND

• Expert 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.

  PMID: 32370979 BACKGROUND

MeSH Terms

Interventions

Technetium Tc 99m Pentetate; Furosemide

Intervention Hierarchy (Ancestors)

Pentetic Acid; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Organotechnetium Compounds; Organometallic Compounds; Sulfanilamides; Sulfonamides; Amides; Aniline Compounds; Sulfones; Sulfur Compounds

Central Study Contacts

Mahytab Abdelhafez Ezzat, Bachelor

CONTACT

0201096549745; mahytababdelhafezmaster@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 30, 2026
• First Posted: September 10, 2026
• Study Start: August 26, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: September 10, 2026

Record last verified: 2026-09