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

Glioma (Diagnosis) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02971319
• Other study ID #: Gliomark
• Status: Completed
• Phase: Phase 2
• First received: November 16, 2016
• Last updated: January 24, 2018
• Start date: September 2016
• Est. completion date: December 17, 2017

Study information

• Verified date: January 2018
• Source: Proactina S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 17, 2017
• Est. primary completion date: November 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• Glioma (Diagnosis)
• Necrosis
• Recurrence

Intervention

Device:
• Tc-99M-Tetrofosmin SPECT

• F-18 FDG PET

Locations

Country	Name	City	State
France	Service de Neurologie Mazarin Hôpital Pitié-Salpêtrière	Paris
Hungary	Országos Klinikai Idegtudományi Intézet (OKITI)	Budapest
Hungary	Országos Onkológiai Intézet	Budapest
Hungary	Pozitron-Diagnosztika Ltd.	Budapest
Hungary	Scanomed Budapest	Budapest
Hungary	Uzsoki Utcai Kórház	Budapest
Hungary	Debreceni Egyetem Orvos- és Egészségtudományi Centrum	Debrecen
Hungary	Scanomed Debrecen	Debrecen
Hungary	Pécsi Tudományegyetem, Általános	Pecs

Sponsors (4)

Lead Sponsor	Collaborator
Proactina S.A.	ConsulTech GmbH, Pharmathen S.A., pharmtrace

Countries where clinical trial is conducted

France,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical performance of Tc-99m tetrofosmin SPECT		assessed once within 3 weeks of inclusion