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Completed

NCT Number: NCT02971319

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

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.

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Key information

Conditions

Glioma (Diagnosis) Disease Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Service de Neurologie Mazarin Hôpital Pitié-Salpêtrière, Paris, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • age: less than18 years
  • 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)
  • 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

Treatment and study plan

Tc-99M-Tetrofosmin SPECT

Device

F-18 FDG PET

Device

Primary outcomes

  1. Technical performance of Tc-99m tetrofosmin SPECT

    Time frame: assessed once within 3 weeks of inclusion

Sponsors and collaborators

Lead sponsor

Proactina S.A.

Other

Collaborators

  • ConsulTech GmbH
  • Pharmathen S.A.
  • pharmtrace

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 22, 2016
Registry last updated
Jan 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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