Study to assess the value of a nuclear medicine procedure (Tc-99m tetrofosmin SPECT) to identify tumor recurrence in patients with brain tumors after radiation therapy.

Phase 1

• Conditions: Patients with high grade brain tumors; MedDRA 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]

• Registration Number: EUCTR2015-005573-21-HU
• Lead Sponsor: pro-ACTINA S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-09
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 51

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
F.1.3.1 Number of subjects for this age range 17

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the technical performance of Tc-99m tetrofosmin SPECT;Secondary Objective: To obtain estimates of the diagnostic performance of Tc-99m tetrofosmin SPECT;Primary end point(s): inter-reader variability in differentiation between radiation necrosis and brain tumor recurrence;Timepoint(s) of evaluation of this end point: end of trial

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): sensitivity, specificity, positive predictive value and negative predictive value of Tc-99m tetrofosmin SPECT and F-18 FDG PET (determined by [1] the local investigator and [2] by 5 independent readers against the final assessment of the truth panel as standard of reference)<br><br>image quality and diagnostic confidence (determined by 1 independent reader from SPECT imaging)<br><br>safety of Tc-99m tetrofosmin and F-18 FDG (AEs, SAEs, vital signs);Timepoint(s) of evaluation of this end point: end of trial