Technetium Tc 99m Dimercaptosuccinic Acid and SPECT with pentavalent 99mTc DMSA in Brain Glioma - Clinical Trials Registry

Study Overview

Status

Not yet recruiting

Conditions

Brain Glioma

Intervention / Treatment

Radiation: SPECT with pentavalent 99mTc DMSA

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 Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Radwa Elsaady, Bachelor
Phone Number: +201006414845
Email: noooor2.2010@gmail.com

Study Contact Backup

Name: Reham Gaber, master
Phone Number: +201156138738
Email: Rehamgaber333@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IDH mutation Time Frame: Baseline	measured by immunohistochemistry technique using the anti-IDH antibody	Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2022

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

October 20, 2022

First Submitted That Met QC Criteria

October 23, 2022

First Posted (Actual)

October 25, 2022

Study Record Updates

Last Update Posted (Actual)