NCT02971319

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_2

Geographic Reach
2 countries

9 active sites

Status
completed

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

Study Start

First participant enrolled

September 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 22, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2017

Completed
Last Updated

January 26, 2018

Status Verified

January 1, 2018

Enrollment Period

1.2 years

First QC Date

November 16, 2016

Last Update Submit

January 24, 2018

Conditions

Glioma (Diagnosis)

Outcome Measures

Primary Outcomes (1)

  • Technical performance of Tc-99m tetrofosmin SPECT

    assessed once within 3 weeks of inclusion

Interventions

Tc-99M-Tetrofosmin SPECTDEVICE
F-18 FDG PETDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • age: less than18 years
  • contraindications for Tc-99m tetrofosmin
  • contraindications for F-18 FDG
  • close affiliation with the investigational site; e.g. first-degree relative of the investigator
  • participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial
  • having been previously enrolled in this clinical trial
  • being mentally disabled
  • mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial
  • Being clinically unstable or requiring emergency treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Service de Neurologie Mazarin Hôpital Pitié-Salpêtrière

Paris, France

Location

Országos Klinikai Idegtudományi Intézet (OKITI)

Budapest, Hungary

Location

Országos Onkológiai Intézet

Budapest, Hungary

Location

Pozitron-Diagnosztika Ltd.

Budapest, Hungary

Location

Scanomed Budapest

Budapest, Hungary

Location

Uzsoki Utcai Kórház

Budapest, Hungary

Location

Debreceni Egyetem Orvos- és Egészségtudományi Centrum

Debrecen, Hungary

Location

Scanomed Debrecen

Debrecen, Hungary

Location

Pécsi Tudományegyetem, Általános

Pécs, Hungary

Location

MeSH Terms

Conditions

GliomaDisease

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissuePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2016

First Posted

November 22, 2016

Study Start

September 1, 2016

Primary Completion

November 17, 2017

Study Completion

December 17, 2017

Last Updated

January 26, 2018

Record last verified: 2018-01

Locations

FR(1)HU(8)