NCT03879005

Brief Summary

To evaluate split renal function using Tc-99m DTPA versus Tc-99m DMSA.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

5 months

First QC Date

March 8, 2019

Last Update Submit

March 19, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Split renal function using 99mTc-DTPA versus 99mTc-DMSA in kidney patients of wide age ranges.

    To emphasize that split renal function calculated with Tc-99m DTPA is as reliable as Tc-99m DMSA

    one year

Study Arms (1)

Renal scintigraphy

OTHER

5 mci of 99mTc-DTPA or 99mTc-DMSA is injected once IV. Dose is adjusted according to age and weight.

Other: renal scintigraphy

Interventions

99mTc-DTPA Scintigraphy Five mci of 99mTc-DTPA will be injected by IV route together with diuretic. Dose will be adjusted according to the age and weight of the patients. A total of 20 min dynamic imaging followed by calculation of GFR and SRF according to the built-in processing protocol Gate's method. 99mTc-DMSA scintigraphy Five mci of 99mTc- DMSA will be injected by IV route with adjustment according to age and weight. Static images will be acquired in the posterior, anterior, andposterior oblique projections for 60 s each.

Also known as: 99mTc-DTPA & 99mTc-DMSA renal scintigraphy
Renal scintigraphy

Eligibility Criteria

Age2 Months - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Kidney patients of wide age ranges.
  • Patients with renal disorders who referred for DMSA and DTPA split renal function.
  • Patients able to sleep in a fixed position for 20 minutes.

You may not qualify if:

  • Children unable to sit calm without movement during imaging.
  • Severely ill patients.
  • Patients with allergy to one or more of material method.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Ardela Diaz E, Miguel Martinez B, Gutierrez Duenas JM, Diez Pascual R, Garcia Arcal D, Dominguez Vallejo FJ. [Comparative study of differential renal function by DMSA and MAG-3 in congenital unilateral uropathies]. Cir Pediatr. 2002 Jul;15(3):118-21. Spanish.

  • Cao X, Xu X, Grant FD, Treves ST. Estimation of Split Renal Function With 99mTc-DMSA SPECT: Comparison Between 3D Volumetric Assessment and 2D Coronal Projection Imaging. AJR Am J Roentgenol. 2016 Dec;207(6):1324-1328. doi: 10.2214/AJR.16.16307. Epub 2016 Sep 13.

  • Celik T, Yalcin H, Gunay EC, Ozen A, Ozer C. Comparison of the Relative Renal Function Calculated with 99mTc-Diethylenetriaminepentaacetic Acid and 99mTc-Dimercaptosuccinic Acid in Children. World J Nucl Med. 2014 Sep;13(3):149-53. doi: 10.4103/1450-1147.144812.

  • Lee WG, Kim JH, Kim JM, Shim KM, Kang SS, Chae HI, Choi SH. Renal uptakes of 99mTc-MAG3, 99mTc-DTPA, and 99mTc-DMSA in rabbits with unilateral ureteral obstruction. In Vivo. 2010 Mar-Apr;24(2):137-9.

Study Officials

  • Mohamed AH Mekkawy, professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Marwa F Abd El Hay

CONTACT

Waleed A Diab, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

March 8, 2019

First Posted

March 18, 2019

Study Start

April 1, 2019

Primary Completion

September 1, 2019

Study Completion

October 1, 2019

Last Updated

March 21, 2019

Record last verified: 2019-03