NCT05595863

Brief Summary

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.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.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.

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 Nov 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

First Submitted

Initial submission to the registry

October 23, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 27, 2022

Status Verified

October 1, 2022

Enrollment Period

1 year

First QC Date

October 23, 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 99m Tc-DMSA (V) uptake by SPECT/CT as a biomarker for IDH mutation

    Baseline

Secondary Outcomes (1)

  • IDH mutation

    Baseline

Eligibility Criteria

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

Glioma patients visiting the nuclear medicine unit in 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 gaber Elsaady

CONTACT

Study Design

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

Study Record Dates

First Submitted

October 23, 2022

First Posted

October 27, 2022

Study Start

November 1, 2022

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

October 27, 2022

Record last verified: 2022-10