Phase II trial: RGD PET/MRI in sporadic Vestibular Schwannoma

Phase 1

• Conditions: Vestibularis Schwannoma; MedDRA version: 20.0Level: LLTClassification code 10048925Term: Acoustic schwannomaSystem Organ Class: 100000014065; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2017-002604-27-DK
• Lead Sponsor: Department of Clinical Physiology, Nuclear Medicin and PET

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-10
• Last Update Posted: 22 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Patients who are either newly diagnosed with a MR-confirmed vestibularis schwannoma or patients who have been in the wactfull waiting regime for under 12 month and have only received 1 controlscan. The patients must be capable of understanding and giving informed written consent.
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

•Pregnancy
•Non-MR compatible implants
•Lactation
•claustrofobi
•Hormone treatment incl. birthcontrol pills
•Steroid treatment
•Obesity (> 140 kg)
•Known allergy to the PET-tracer 68Ga-NODAGA-E[c(RGDyK)]2

Study & Design

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