Vestibularis Schwannoma MedDRA version: 20.0 Level: LLT Classification code 10048925 Term: Acoustic schwannoma System Organ Class: 100000014065
Conditions
Interventions
Product Name: 68Ga-NODAGA-E[c(RGDyK)]2
Product Code: 68Ga-NODAGA-ENo p[c(RGDyK)]2
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: 68Ga-NODAGA-E[c(RGDyK)]2
Sponsors
Department of Clinical Physiology, Nuclear Medicin and PET
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objektive of this study is to test whether the new radio tracer 68Ga-NODAGA-E[c(RGDyK)]2 for PET imaging of angiogenises. The tracer combined with PET-MR has the potential to provide a novel non-invasive prognostic method for the growth rate of vestibularis schwannomas, as the growth rate of vestibularis schwannomas has been correlated with pro-angiogenetic markers. This is a phase II trial in patients with a benign intracranial tumor. Uptake of the tracer will be correlated to the growth rate by PET-MR and MR scans.;Secondary Objective: Tumor uptake of 68Ga-NODAGA-E[c(RGDyK)]2 will be compared to the expression of pro-angiogenetic marker using RNA sequencing in tumor tissue obtained from operative removal of the tumor.;Primary end point(s): The correlation between the quantative tumor uptake of the PET-tracer 68Ga-NODAGA-E[c(RGDyK)]2 and the tumors growth rate decided by an additional MR-scan minimum 2 month later.;Timepoint(s) of evaluation of this end point: The patients will undergo a PET/MR-scan and an additional MR-scan minimum 2 month after the PET/MR-scan. These timepoints will be used to determine the tumoruptake as well as the growth rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The correlation between the quantative tumor uptake of the PET-tracer 68Ga-NODAGA-E[c(RGDyK)]2 and the expression of pro-angiogenetic markers via RNA sequencing.;Timepoint(s) of evaluation of this end point: The correlation between the tumoruptake and the expression of the pro-angiogenetic markers. The time points is the PET/MR-scan as well as the RNA sequencing of the tumortissue obtained from surgery. | — |
Countries
Denmark
Contacts
Public ContactHjalte Christian Reeberg Sass
Rigshospitalet, Department of Otorhinolaryngology, Head and Neck Surgery & Audiology
Outcome results
None listed