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

January 24, 2018 updated by: Proactina S.A.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Proactina S.A.

Collaborators

Pharmathen S.A.
ConsulTech GmbH
pharmtrace

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

November 17, 2017

Study Completion (Actual)

December 17, 2017

Study Registration Dates

First Submitted

November 16, 2016

First Submitted That Met QC Criteria

November 21, 2016

First Posted (Estimate)

November 22, 2016

Study Record Updates

Last Update Posted (Actual)

January 26, 2018

Last Update Submitted That Met QC Criteria

January 24, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gliomark

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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