Technical Performance Assessment of Tc-99m Tetrofosmin for Differentiation of Recurrence vs Radiation Necrosis in Patients With Glioma

Exploratory Phase II Study in Patients After Treatment of High Grade Brain Tumors to Assess the Technical Performance of Tc-99m Tetrofosmin for Differentiation of Recurrence Versus Radiation Necrosis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02971319

Enrollment

Registered

2016-11-22

Start date

2016-09-30

Completion date

2017-12-17

Last updated

2018-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioma (Diagnosis)

Brief summary

This study aims to assess the technical performance of Tc-99m tetrofosmin SPECT as compared to F-18 FDG PET for the differentiation of radiation necrosis from glioma relapse and to obtain estimates of diagnostic accuracy for Tc-99m tetrofosmin SPECT and F-18 FDG PET in an intra-individual comparison.

Interventions

DEVICETc-99M-Tetrofosmin SPECT

DEVICEF-18 FDG PET

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. confirmed high grade glioma (e.g., anaplastic astrocytoma, glioblastoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma) 2. being in follow-up for at least 3 months after completion of radiation therapy (with or without concurrent chemotherapy) 3. inconclusive MRI results regarding the differentiation between recurrence and radiation necrosis 4. willing and able to undergo all study procedures 5. informed consent in writing (dated and signed)

Exclusion criteria

1. age: less than18 years 2. if female, pregnant or breast feeding (females of child-bearing potential must use adequate contraception and must have a negative pregnancy test performed within 7 days prior to inclusion into this study) 3. contraindications for Tc-99m tetrofosmin 4. contraindications for F-18 FDG 5. close affiliation with the investigational site; e.g. first-degree relative of the investigator 6. participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial 7. having been previously enrolled in this clinical trial 8. being mentally disabled 9. mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial 10. Being clinically unstable or requiring emergency treatment

Design outcomes

Primary

Measure	Time frame
Technical performance of Tc-99m tetrofosmin SPECT	assessed once within 3 weeks of inclusion

Countries

France, Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026