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

Phase 2

Completed

• Conditions: Glioma (Diagnosis)

• Registration Number: NCT02971319
• Lead Sponsor: Proactina S.A.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-11-16
• Study First Submitted QC: 2016-11-21
• Study First Posted: 2016-11-22
• Primary Completion: 2017-11-17
• Study Completion: 2017-12-17
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-24
• Last Update Posted: 2018-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (9)

Service de Neurologie Mazarin Hôpital Pitié-Salpêtrière; 🇫🇷 Paris, France

Scanomed Debrecen; 🇭🇺 Debrecen, Hungary

Pécsi Tudományegyetem, Általános; 🇭🇺 Pecs, Hungary

Országos Onkológiai Intézet; 🇭🇺 Budapest, Hungary

Debreceni Egyetem Orvos- és Egészségtudományi Centrum; 🇭🇺 Debrecen, Hungary

Országos Klinikai Idegtudományi Intézet (OKITI); 🇭🇺 Budapest, Hungary

Pozitron-Diagnosztika Ltd.; 🇭🇺 Budapest, Hungary

Scanomed Budapest; 🇭🇺 Budapest, Hungary

Uzsoki Utcai Kórház; 🇭🇺 Budapest, Hungary