Brain GliomaNCT05593809
Single Photon Emission Computed Tomography/Computed Tomography With Pentavalent 99mTc Dimercaptosuccinic Acid in Patients With Brain Glioma; Correlation With IDH Mutation
An observational study of Brain Glioma, run by Assiut University.
Trial summary
The aim of this study is to evaluate the correlation between degree of 99mTc-DMSA (V) uptake at SPECT/CT and IDH mutation in patients with brain glioma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Glioma
- What is being tested?
- SPECT with pentavalent 99mTc DMSA
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Nov 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Brain Glioma and satisfy the inclusion criteria visiting the nuclear medicine unit at Assiut university hospital
Who may be able to join
- Patients with a pathologically proven glioma. • patients conscious to provide informed consent
Who cannot join
- Pregnant women.
- severely ill patients and those with disturbed conscious level,
- patients who were judged that they cannot lie down comfortably without movement for at least 20 min
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to evaluate the correlation between degree of 99mTc-DMSA (V) uptake at SPECT/CT and IDH mutation in patients with brain glioma.
Read the detailed description
Every year, nearly100,000 people worldwide are diagnosed as having brain gliomas. Although it comprises <1% of all newly diagnosed cancers, brain glioma is associated with substantial mortality and morbidity. Gliomas are intrinsic brain tumors that originate from neuroglial progenitor cells. Conventional therapies, including surgery, chemotherapy, and radiotherapy, have achieved limited improvements in the prognosis of glioma patients.
Radiation therapy to the brain may lead to postradiation injury which typically occurs within the first 3 to 12 months after radiotherapy but it was reported up to several years and even decades later. The clinical picture of radiation necrosis (RN) is variable and may include seizures, headache, personality changes, and neurologic deficits. These symptoms mimic tumor recurrence and differentiation between the two entities clinically or even by conventional radiological modalities is difficult but is necessary because the two conditions have different treatment modalities and prognosis.
SPECT has the advantages of being widely available and not expensive. Multiple SPECT tracers have been explored. Of them Thallium-201 and 99 mTc-MIBI are, possibly, the most extensively discussed. The main disadvantage of 201Tl is the lower spatial resolution, relatively large radiation dose, and the reported high false positive results. Normal uptake of MIBI in the choroid plexus may be confounding for assessing tumors around the ventricles.
Pentavalent 99mTc dimercaptosuccinic acid (99mTc (V) DMSA), is a nonspecific tumor targeting SPECT radiotracer, that has been used for imaging of various tumors including lung and breast carcinoma. However, to date, scarce reports discussed the utility of DMSA-V in patients with glioma.
Isocitrate dehydrogenase (IDH) enzymes, of which there are three isoforms, are essential enzymes that participate in several major metabolic processes, such as the Krebs cycle, glutamine metabolism, lipogenesis and redox regulation.
Major advances in cancer genetics over the past decade have revealed that the genes encoding IDHs are frequently mutated in a variety of human malignancies, including gliomas, acute myeloid leukaemia, cholangiocarcinoma, chondrosarcoma and thyroid carcinoma.
- Conditions
- Brain Glioma
- Being tested
- SPECT with pentavalent 99mTc DMSA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECT with pentavalent 99mTc DMSARadiation
A dose of 555-740 MBq 99mTc (V) DMSA is injected into a peripheral vein. Delayed brain SPECT/CT images will be obtained at 2-3 h after injection. Imaging will be performed on a hybrid dual head SPECT/CT machine (Symbia T, Siemens, Erlangen, Germany) fitted with a low energy high-resolution collimator, using 15% energy window set at 140 keV.
SPECT images are acquired in a noncircular 360° arc for a total of 64 frames, 25-s/frame, using a 128 × 128 matrix size. Following SPECT acquisition, low-dose CT is acquired for anatomical localization and attenuation correction. The used CT parameters are: tube voltage 130 kV, tube current 80 mA, and slice thickness 1 mm. Images will be reconstructed using manufacturer's iterative protocol (four iterations, four subsets, and Gaussian filter 8 mm). The reconstructed images will be reviewed on a viewing workstation running OsiriX MD version 6.5.2 (Pixmeo, Bernex, Switzerland).
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of 99mTc-DMSA (V) uptake at SPECT/CT
measured by calculating quantitative index of 99mTc-DMSA (V) uptake at SPECT/CT as a biomarker for IDH mutation expression
Measured: Baseline
Secondary outcomes (1)
IDH mutation
measured by immunohistochemistry technique using the anti-IDH antibody
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study startOct 2022 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain GliomaStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Gaber Elsaady, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593809
- Sponsor's protocol ID
- DMSAglioma
- Status last verified
- Oct 2022
- First submitted
- 20 Oct 2022
- Last updated
- 25 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Photon Emission Computed Tomography/Computed Tomography With Pentavalent 99mTc Dimercaptosuccinic Acid in Patients With Brain Glioma; Correlation With IDH Mutation
- ClinicalTrials.gov ID
- NCT05593809
- Acronym / sponsor ID
- DMSAglioma
- Conditions
- Brain Glioma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 25 Oct 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.
The aim of this study is to evaluate the correlation between degree of 99mTc-DMSA (V) uptake at SPECT/CT and IDH mutation in patients with brain glioma.
Detailed description
Every year, nearly100,000 people worldwide are diagnosed as having brain gliomas. Although it comprises <1% of all newly diagnosed cancers, brain glioma is associated with substantial mortality and morbidity. Gliomas are intrinsic brain tumors that originate from neuroglial progenitor cells. Conventional therapies, including surgery, chemotherapy, and radiotherapy, have achieved limited improvements in the prognosis of glioma patients.
Radiation therapy to the brain may lead to postradiation injury which typically occurs within the first 3 to 12 months after radiotherapy but it was reported up to several years and even decades later. The clinical picture of radiation necrosis (RN) is variable and may include seizures, headache, personality changes, and neurologic deficits. These symptoms mimic tumor recurrence and differentiation between the two entities clinically or even by conventional radiological modalities is difficult but is necessary because the two conditions have different treatment modalities and prognosis.
SPECT has the advantages of being widely available and not expensive. Multiple SPECT tracers have been explored. Of them Thallium-201 and 99 mTc-MIBI are, possibly, the most extensively discussed. The main disadvantage of 201Tl is the lower spatial resolution, relatively large radiation dose, and the reported high false positive results. Normal uptake of MIBI in the choroid plexus may be confounding for assessing tumors around the ventricles.
Pentavalent 99mTc dimercaptosuccinic acid (99mTc (V) DMSA), is a nonspecific tumor targeting SPECT radiotracer, that has been used for imaging of various tumors including lung and breast carcinoma. However, to date, scarce reports discussed the utility of DMSA-V in patients with glioma.
Isocitrate dehydrogenase (IDH) enzymes, of which there are three isoforms, are essential enzymes that participate in several major metabolic processes, such as the Krebs cycle, glutamine metabolism, lipogenesis and redox regulation.
Major advances in cancer genetics over the past decade have revealed that the genes encoding IDHs are frequently mutated in a variety of human malignancies, including gliomas, acute myeloid leukaemia, cholangiocarcinoma, chondrosarcoma and thyroid carcinoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Brain Glioma and satisfy the inclusion criteria visiting the nuclear medicine unit at Assiut university hospital
Key inclusion criteria (1 listed)
- Patients with a pathologically proven glioma. • patients conscious to provide informed consent
Key exclusion criteria (3 listed)
- Pregnant women.
- severely ill patients and those with disturbed conscious level,
- patients who were judged that they cannot lie down comfortably without movement for at least 20 min
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 |
|---|---|---|
| SPECT with pentavalent 99mTc DMSAA dose of 555-740 MBq 99mTc (V) DMSA is injected into a peripheral vein. Delayed brain SPECT/CT images will be obtained at 2-3 h after injection. Imaging will be performed on a hybrid dual head SPECT/CT machine (Symbia T, Siemens, Erlangen, Germany) fitted with a low energy high-resolution collimator, using 15% energy window set at 140 keV. SPECT images are acquired in a noncircular 360° arc for a total of 64 frames, 25-s/frame, using a 128 × 128 matrix size. Following SPECT acquisition, low-dose CT is acquired for anatomical localization and attenuation correction. The used CT parameters are: tube voltage 130 kV, tube current 80 mA, and slice thickness 1 mm. Images will be reconstructed using manufacturer's iterative protocol (four iterations, four subsets, and Gaussian filter 8 mm). The reconstructed images will be reviewed on a viewing workstation running OsiriX MD version 6.5.2 (Pixmeo, Bernex, Switzerland). | Radiation | – |
Primary outcome
degree of 99mTc-DMSA (V) uptake at SPECT/CT
Time frame: Baseline
measured by calculating quantitative index of 99mTc-DMSA (V) uptake at SPECT/CT as a biomarker for IDH mutation expression
1 secondary outcome
IDH mutation
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Glioma, 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 1 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 25 Oct 2022. 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 Radwa Elsaady, Bachelor (+201006414845, noooor2.2010@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
degree of 99mTc-DMSA (V) uptake at SPECT/CT (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2022; AzTrials last refreshed its copy on 30 Oct 2026.