Acoustic Neuroma
Conditions
Keywords
68Ga-NODAGA-E[c(RGDyK)]2, Angiogenesis PET/MR, Acoustic Neuroma
Brief summary
The aim of this non-randomised, prospective study is to investigate the applicability and prognostic value of angiogenesis PET/MR with the radioligand 68Ga-NODAGA- E\[c(RGDyK)\]2 in patients with sporadic Vestibuarl Schwannomas.
Detailed description
The radioligand 68Ga-NODAGA- E\[c(RGDyK)\]2 targets the Arg-Gly-Asp (RGD) sequence known to bind with the αvβ3 integrin that is expressed on the surface of angiogenic blood vessels or tumor cells. The radioligand can be used to visualize tumor angiogenesis using PET/MR. A total of 40 patients diagnosed with sporadic vestibular schwannomas will be subjected to an angiogenesis-PET/MR scan. Follow-up MR-only scan will be performed (from the time of the angiogenesis PET/MR) minimum 2 months later in regards to calculate growth rate. The uptake of 68Ga-NODAGA-E\[c(RGDyK)\]2 (Standardized Uptake Values, SUVmax) in tumor lesions will be quantified as Standardized Uptake Values (SUVmax/SUVmean) and compared with PFS, DSS and OS (dichotomized above/below median SUVmax and analyzed by Kaplan-Meier).
Interventions
One injection of 68Ga-NODAGA-E\[c(RGDyK)\]2
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients \> 18 years with MRI verified sporadic vestibular schwannomas * Patients \> 18 år whom max has been in watchful waiting regime in 12 months and/or max. received 1 follow-up MRI scan. * Must be able to read and understand the patient information in Danish and to give informed consent
Exclusion criteria
* Pregnancy * Breast-feeding * Weight more than the maximum weight limit for the PET/MR bed of the scanner (140 kg) * History of allergic reaction attributable to compounds of similar chemical or biologic composition to 68Ga-NODAGA-E\[c(RGDyK)\]2 * Recent systemic treatment with steroids * Hormone treatment incl. birth control pills. * Claustrofobia * Non-MRI compatible implants.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Angiogenesis PET/MR imaging of patients with sporadic Vestibular Schwannomas | 1 hour | The radioligand 68Ga-NODAGA-E\[c(RGDyK)\]2 can be used as a prognostic marker for growth rate in patients with sporadic vestibular schwannomas. |
Countries
Denmark
Contacts
Primary ContactHjalte C.R. Sass, MD, Phd-fellow
Backup ContactAndreas Kjær, DMSci, Phd, Professor
Outcome results
None listed