NCT05593809

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 25, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

1 year

First QC Date

October 20, 2022

Last Update Submit

October 23, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline

Secondary Outcomes (1)

  • IDH mutation

    Baseline

Interventions

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).

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients with a pathologically proven glioma. • patients conscious to provide informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Central Study Contacts

Radwa Elsaady, Bachelor

CONTACT

Reham Gaber, master

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

October 20, 2022

First Posted

October 25, 2022

Study Start

October 1, 2022

Primary Completion

October 1, 2023

Study Completion

November 1, 2023

Last Updated

October 25, 2022

Record last verified: 2022-10