EUCTR2015-005573-21-HU
Active, not recruiting
Phase 1
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 - GLIOMARK1
pro-ACTINA S.A.0 sites51 target enrollmentJune 9, 2016
ConditionsPatients with high grade brain tumorsMedDRA version: 20.0Level: PTClassification code 10065443Term: Malignant gliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsMyoview
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with high grade brain tumors
- Sponsor
- pro-ACTINA S.A.
- Enrollment
- 51
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
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)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 34
- •F.1\.3 Elderly (\>\=65 years) yes
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
Outcomes
Primary Outcomes
Not specified
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