Clinical trial NCT02971319: Technical Performance Assessment of Tc-99m Tetrofosmin for Differentiation of Recurrence vs Radiation Necrosis in Patients With Glioma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glioma (Diagnosis)
Lead sponsor: Proactina S.A.
Sponsor class: OTHER
Collaborators: name: ConsulTech GmbH
name: pharmtrace
name: Pharmathen S.A.
First posted: 2016-11-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Technical performance of Tc-99m tetrofosmin SPECT
timeFrame: assessed once within 3 weeks of inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Neurologie Mazarin Hôpital Pitié-Salpêtrière
city: Budapest
country: Hungary
facility: Országos Klinikai Idegtudományi Intézet (OKITI)
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet
city: Budapest
country: Hungary
facility: Pozitron-Diagnosztika Ltd.
city: Budapest
country: Hungary
facility: Scanomed Budapest
city: Budapest
country: Hungary
facility: Uzsoki Utcai Kórház
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum
city: Debrecen
country: Hungary
facility: Scanomed Debrecen
city: Pecs
country: Hungary
facility: Pécsi Tudományegyetem, Általános
Study officials:
References: