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Trial Title: Single Photon Emission Computed Tomography/Computed Tomography With Pentavalent 99mTc Dimercaptosuccinic Acid in Patients With Brain Glioma; Correlation With IDH Mutation

NCT ID: NCT05593809

Condition: Brain Glioma

Conditions: Official terms:
Glioma
Technetium Tc 99m Dimercaptosuccinic Acid

Study type: Observational

Overall status: Unknown status

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Radiation
Intervention name: SPECT with pentavalent 99mTc DMSA
Description: 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).

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.

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.

Criteria for eligibility:

Study pop:
Patients with Brain Glioma and satisfy the inclusion criteria visiting the nuclear medicine unit at Assiut university hospital

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - Patients with a pathologically proven glioma. • patients conscious to provide informed consent Exclusion Criteria: - 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

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Start date: October 2022

Completion date: November 2023

Lead sponsor:
Agency: Assiut University
Agency class: Other

Source: Assiut University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05593809
https://pubmed.ncbi.nlm.nih.gov/31227792/
https://pubmed.ncbi.nlm.nih.gov/19381441/
https://pubmed.ncbi.nlm.nih.gov/21912937/
https://pubmed.ncbi.nlm.nih.gov/7830114/
https://pubmed.ncbi.nlm.nih.gov/20143189/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7250901/
https://pubmed.ncbi.nlm.nih.gov/15586883/

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