The Difference in Estimation of Split Renal Function Using the Two Radiopharmaceuticals:Tc-99m DTPA & Tc-99m DMSA in Kidney PatientsNCT03879005
Split Renal Function Using 99mTc-DTPA Versus 99mTc-DMSA in Kidney Patients of Wide Age Ranges.
A study testing renal scintigraphy in people with The Difference in Estimation of Split Renal Function Using the Two Radiopharmaceuticals:Tc-99m DTPA & Tc-99m DMSA in Kidney Patients, run by Assiut University.
Trial summary
To evaluate split renal function using Tc-99m DTPA versus Tc-99m DMSA. Read more about this study
- Who is it for?
- Ages 2 months to 80 years
- Conditions the study is for
- The Difference in Estimation of Split Renal Function Using the Two Radiopharmaceuticals:Tc-99m DTPA & Tc-99m DMSA in Kidney Patients
- What is being tested?
- renal scintigraphy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Apr 2019to Oct 2019
- Phase
- Interventional
- 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 2 months to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Children unable to sit calm without movement during imaging.
- Severely ill patients.
- Patients with allergy to one or more of material method.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Split Renal Function Using 99mTc-DTPA Versus 99mTc-DMSA in Kidney Patients of Wide Age Ranges
To evaluate split renal function using Tc-99m DTPA versus Tc-99m DMSA.
Read the detailed description
Split renal function (SPR) is a determination of the relative contribution of each of the two kidneys . It gives a useful information in several conditions such as evaluating unilateral renal disorders, assessing individual kidney function before and after intervention, and before live donor nephrectomy. Different radiopharmaceuticals such as technetium-99m dimercaptosuccinic acid (99mTc-DMSA), technetium-99m diethylenetriaminepentaaceticacid (99mTc-DTPA), technetium-99m mercaptoacetyltriglycine (99mTc-MAG3), Iodine 131 orthoiodohippurate and more recently technetium-99 m ethylenedicysteine (99mTc-EC) were used, However, 99mTc-DMSA as a static renal agent is considered the most reliable method to measure relative renal function and the most appropriate tracer for renal cortical imaging . In some papers, it is emphasized that relative renal function calculated with 99mTc-DTPA is as reliable as 99mTc-DMSA . The investigators design the study to evaluate the difference in estimation of split renal function using the available two radiopharmaceuticals: Tc-99m DTPA and Tc-99m DMSA.
- Being tested
- renal scintigraphy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal scintigraphyOther
Also called 99mTc-DTPA & 99mTc-DMSA renal scintigraphy
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.
| Study group | Role | What they receive |
|---|---|---|
| Renal scintigraphy | Other | 5 mci of 99mTc-DTPA or 99mTc-DMSA is injected once IV. Dose is adjusted according to age and weight. Receives: Other: renal scintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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 posted18 Mar 2019
- Study startApr 2019 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionOct 2019 (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 The Difference in Estimation of Split Renal Function Using the Two Radiopharmaceuticals:Tc-99m DTPA & Tc-99m DMSA in Kidney PatientsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Fathy, Assiut University
- Investigators
- Mohamed AH Mekkawy, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879005
- Sponsor's protocol ID
- SRF using DTPA Vs DMSA
- Status last verified
- Mar 2019
- First submitted
- 8 Mar 2019
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 12601986Cao 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.
PubMed 27623376Celik 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.
PubMed 25538484Lee 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.
PubMed 20363984
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Split Renal Function Using 99mTc-DTPA Versus 99mTc-DMSA in Kidney Patients of Wide Age Ranges
- ClinicalTrials.gov ID
- NCT03879005
- Acronym / sponsor ID
- SRF using DTPA Vs DMSA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2019 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 18 Mar 2019 (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.
To evaluate split renal function using Tc-99m DTPA versus Tc-99m DMSA.
Detailed description
Split renal function (SPR) is a determination of the relative contribution of each of the two kidneys . It gives a useful information in several conditions such as evaluating unilateral renal disorders, assessing individual kidney function before and after intervention, and before live donor nephrectomy. Different radiopharmaceuticals such as technetium-99m dimercaptosuccinic acid (99mTc-DMSA), technetium-99m diethylenetriaminepentaaceticacid (99mTc-DTPA), technetium-99m mercaptoacetyltriglycine (99mTc-MAG3), Iodine 131 orthoiodohippurate and more recently technetium-99 m ethylenedicysteine (99mTc-EC) were used, However, 99mTc-DMSA as a static renal agent is considered the most reliable method to measure relative renal function and the most appropriate tracer for renal cortical imaging . In some papers, it is emphasized that relative renal function calculated with 99mTc-DTPA is as reliable as 99mTc-DMSA . The investigators design the study to evaluate the difference in estimation of split renal function using the available two radiopharmaceuticals: Tc-99m DTPA and Tc-99m DMSA.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal scintigraphy | Other | Other: renal scintigraphy5 mci of 99mTc-DTPA or 99mTc-DMSA is injected once IV. Dose is adjusted according to age and weight. |
Who may qualify
- Ages
- 2 months to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Children unable to sit calm without movement during imaging.
- Severely ill patients.
- Patients with allergy to one or more of material method.
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 |
|---|---|---|
| renal scintigraphyAlso: 99mTc-DTPA & 99mTc-DMSA renal scintigraphy99mTc-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. | Other | Renal scintigraphy |
Primary outcome
Split renal function using 99mTc-DTPA versus 99mTc-DMSA in kidney patients of wide age ranges.
Time frame: one year
To emphasize that split renal function calculated with Tc-99m DTPA is as reliable as Tc-99m DMSA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Results publication: PubMed 12601986Ardela 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.
- Results publication: PubMed 27623376Cao 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.
- Results publication: PubMed 25538484Celik 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.
- Results publication: PubMed 20363984Lee 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.
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 AH Mekkawy, professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing renal scintigraphy in people with The Difference in Estimation of Split Renal Function Using the Two Radiopharmaceuticals:Tc-99m DTPA & Tc-99m DMSA in Kidney Patients, 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 21 Mar 2019. 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 Marwa F Abd El Hay (0102291658, f.marwa1992@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Split renal function using 99mTc-DTPA versus 99mTc-DMSA in kidney patients of wide age ranges. (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 NCT03879005, 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 21 Mar 2019.