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

Primary Purpose

Glioma (Diagnosis)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tc-99M-Tetrofosmin SPECT
F-18 FDG PET
Sponsored by
Proactina S.A.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glioma (Diagnosis)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Outcomes

Primary Outcome Measures

Technical performance of Tc-99m tetrofosmin SPECT

Secondary Outcome Measures

Full Information

First Posted
November 16, 2016
Last Updated
January 24, 2018
Sponsor
Proactina S.A.
Collaborators
ConsulTech GmbH, pharmtrace, Pharmathen S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT02971319
Brief Title
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

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
November 17, 2017 (Actual)
Study Completion Date
December 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Proactina S.A.
Collaborators
ConsulTech GmbH, pharmtrace, Pharmathen S.A.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma (Diagnosis)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Tc-99M-Tetrofosmin SPECT
Intervention Type
Device
Intervention Name(s)
F-18 FDG PET
Primary Outcome Measure Information:
Title
Technical performance of Tc-99m tetrofosmin SPECT
Time Frame
assessed once within 3 weeks of inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Service de Neurologie Mazarin Hôpital Pitié-Salpêtrière
City
Paris
Country
France
Facility Name
Országos Klinikai Idegtudományi Intézet (OKITI)
City
Budapest
Country
Hungary
Facility Name
Országos Onkológiai Intézet
City
Budapest
Country
Hungary
Facility Name
Pozitron-Diagnosztika Ltd.
City
Budapest
Country
Hungary
Facility Name
Scanomed Budapest
City
Budapest
Country
Hungary
Facility Name
Uzsoki Utcai Kórház
City
Budapest
Country
Hungary
Facility Name
Debreceni Egyetem Orvos- és Egészségtudományi Centrum
City
Debrecen
Country
Hungary
Facility Name
Scanomed Debrecen
City
Debrecen
Country
Hungary
Facility Name
Pécsi Tudományegyetem, Általános
City
Pecs
Country
Hungary

12. IPD Sharing Statement

Learn more about this trial

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

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