Patients Referred for Renal DMSA ScintigraphyNCT05344807
Role OF Geometric Mean in Estimation OF Differential Renal Function in DMSA Scintigraphy
An observational study of Patients Referred for Renal DMSA Scintigraphy, run by Sohag University at 1 site in Egypt.
Trial summary
Renal scintigraphy is an imaging method that uses small amount of radioactive materials called radiotracers, a Gamma camera and a computer to evaluate kidney functions and its anatomy. Read more about this study
- Who is it for?
- Ages 2 to 70 years
- Conditions the study is for
- Patients Referred for Renal DMSA Scintigraphy
- What is being tested?
- Renal DMSA Scintigraphy
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- May 2022to Nov 2022
- 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 2 to 70 years
- All sexes
- Child, Adult, Older adult
Study population: • Patients referred for renal DMSA scintigraphy
Who may be able to join
- Patients referred for renal DMSA scintigraphy
- Patients aging 2 to 70 years
Who cannot join
- Single kidney patients
- Patients with a major uncontrollable medical illness.
Trial locations and contacts
1 site in 1 country.
Mohamed s gaber, professor contact
About this study
Renal scintigraphy is an imaging method that uses small amount of radioactive materials called radiotracers, a Gamma camera and a computer to evaluate kidney functions and its anatomy.
The relative renal function (RRF), expressed as a percent of total renal function, is important in the initial assessment and treatment of patients having renal diseases. RRF has traditionally been measured by radionuclide renal scintigraphies using different tracers for a long time . Different radiopharmaceuticals such as technetium-99m-diethylenetriaminepentaacetic acid (99mTc-DTPA), technetium-99m-dimercaptosuccinic acid (99mTc-DMSA), technetium-99m-mercaptoacetyltriglycine (99mTc-MAG3).
Read more
99mTc-DMSA is a static agent that is actively taken up by the proximal and distal renal tubular cells, directly from the peritubular vessels and accumulates in the renal cortex. Its binding level to protein in mammals is 90% which prevents significant glomerular filtration. DMSA renal scan images provide a good definition of the cortical outline, as well as they show the relative distribution of functional tissue.
Determination of the left to right dimercaptosuccinic acid (DMSA) uptake ratio is theoretically one of the easiest quantitative procedures in nuclear medicine. The quantification can be performed on the posterior view, with or without the lateral view for correction of kidney depth. The geometric mean can also be determined using both the anterior and the posterior views.
- Being tested
- Renal DMSA Scintigraphy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal DMSA ScintigraphyDiagnostic test
patient injected with Tc99mDMSA then imaged after 2-4 hours by gamma camera
What is being measured
The primary outcome is the main question the study is designed to answer.
geometric mean of both anterior and posterior views of gamma camera
. We evaluate the discrepancy between function measured by conjugate anterior and posterior views in relationship to posterior view in DMSA scan .
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study startMay 2022 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patients Referred for Renal DMSA ScintigraphyStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shrouk Atef Abdelsalam, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344807
- Sponsor's protocol ID
- Soh-Med-22-04-06
- Status last verified
- Apr 2022
- First submitted
- 18 Apr 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Arteaga MV, Caballero VM, Rengifo KM. Dosimetry of 99mTc (DTPA, DMSA and MAG3) used in renal function studies of newborns and children. Appl Radiat Isot. 2018 Aug;138:25-28. doi: 10.1016/j.apradiso.2017.07.054. Epub 2017 Jul 28.
PubMed 28781122Hervas I, Marti JF, Gonzalez A, Ruiz JC, Alonso J, Bello P, Manzano F, Torres I, Mateo A. Is the depth correction using the geometric mean really necessary in a 99Tcm-DMSA scan in the paediatric population? Nucl Med Commun. 2001 May;22(5):547-52. doi: 10.1097/00006231-200105000-00013.
PubMed 11388577Miyazaki C, Harada H, Shuke N, Okizaki A, Miura M, Hirano T. (99m)Tc-DTPA dynamic SPECT and CT volumetry for measuring split renal function in live kidney donors. Ann Nucl Med. 2010 Apr;24(3):189-95. doi: 10.1007/s12149-010-0349-y. Epub 2010 Mar 9.
PubMed 20213340
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role OF Geometric Mean in Estimation OF Differential Renal Function in DMSA Scintigraphy
- ClinicalTrials.gov ID
- NCT05344807
- Acronym / sponsor ID
- Soh-Med-22-04-06
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 25 Apr 2022 (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.
Renal scintigraphy is an imaging method that uses small amount of radioactive materials called radiotracers, a Gamma camera and a computer to evaluate kidney functions and its anatomy.
The relative renal function (RRF), expressed as a percent of total renal function, is important in the initial assessment and treatment of patients having renal diseases. RRF has traditionally been measured by radionuclide renal scintigraphies using different tracers for a long time . Different radiopharmaceuticals such as technetium-99m-diethylenetriaminepentaacetic acid (99mTc-DTPA), technetium-99m-dimercaptosuccinic acid (99mTc-DMSA), technetium-99m-mercaptoacetyltriglycine (99mTc-MAG3).
99mTc-DMSA is a static agent that is actively taken up by the proximal and distal renal tubular cells, directly from the peritubular vessels and accumulates in the renal cortex. Its binding level to protein in mammals is 90% which prevents significant glomerular filtration. DMSA renal scan images provide a good definition of the cortical outline, as well as they show the relative distribution of functional tissue.
Determination of the left to right dimercaptosuccinic acid (DMSA) uptake ratio is theoretically one of the easiest quantitative procedures in nuclear medicine. The quantification can be performed on the posterior view, with or without the lateral view for correction of kidney depth. The geometric mean can also be determined using both the anterior and the posterior views.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 2 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- • Patients referred for renal DMSA scintigraphy
Key inclusion criteria (2 listed)
- Patients referred for renal DMSA scintigraphy
- Patients aging 2 to 70 years
Key exclusion criteria (2 listed)
- Single kidney patients
- Patients with a major uncontrollable medical illness.
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 DMSA Scintigraphypatient injected with Tc99mDMSA then imaged after 2-4 hours by gamma camera | Diagnostic test | – |
Primary outcome
geometric mean of both anterior and posterior views of gamma camera
Time frame: 6 months
. We evaluate the discrepancy between function measured by conjugate anterior and posterior views in relationship to posterior view in DMSA scan .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Background: PubMed 28781122Arteaga MV, Caballero VM, Rengifo KM. Dosimetry of 99mTc (DTPA, DMSA and MAG3) used in renal function studies of newborns and children. Appl Radiat Isot. 2018 Aug;138:25-28. doi: 10.1016/j.apradiso.2017.07.054. Epub 2017 Jul 28.
- Background: PubMed 11388577Hervas I, Marti JF, Gonzalez A, Ruiz JC, Alonso J, Bello P, Manzano F, Torres I, Mateo A. Is the depth correction using the geometric mean really necessary in a 99Tcm-DMSA scan in the paediatric population? Nucl Med Commun. 2001 May;22(5):547-52. doi: 10.1097/00006231-200105000-00013.
- Background: PubMed 20213340Miyazaki C, Harada H, Shuke N, Okizaki A, Miura M, Hirano T. (99m)Tc-DTPA dynamic SPECT and CT volumetry for measuring split renal function in live kidney donors. Ann Nucl Med. 2010 Apr;24(3):189-95. doi: 10.1007/s12149-010-0349-y. Epub 2010 Mar 9.
- Individual participant dataSharing planned: Undecided
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 s gaber, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Referred for Renal DMSA Scintigraphy, run by Sohag University at 1 site in Egypt.
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 2 inclusion and 2 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 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 shrouk a abdelsalam, resident (01141807272, shourokatef@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
geometric mean of both anterior and posterior views of gamma camera (time frame: 6 months). 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 NCT05344807, which also lists 3 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 Apr 2022.