Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002604-27 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Angiogenesis PET/MR | Experimental | One injection of the radioligand 68Ga-NODAGA-E[c(RGDyK)]2 followed by PET/MR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One injection of 68Ga-NODAGA-E[c(RGDyK)]2 | Drug | One injection of 68Ga-NODAGA-E[c(RGDyK)]2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Angiogenesis PET/MR imaging of patients with sporadic Vestibular Schwannomas | The radioligand 68Ga-NODAGA-E[c(RGDyK)]2 can be used as a prognostic marker for growth rate in patients with sporadic vestibular schwannomas. | 1 hour |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hjalte C.R. Sass, MD, Phd-fellow | Contact | +45 31310730 | hjalte.christian.reeberg.sass.01@regionh.dk | |
| Andreas KjƦr, DMSci, Phd, Professor | Contact | +45 51724829 | andreas.kjaer@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Hjalte C.R. Sass, MD, Ph.d.-Fellow | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Otolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41530428 | Derived | Sass HCR, Jensen RG, Johannesen HH, Lofgren JO, Loft A, Andersen TL, Hansen AE, Caye-Thomasen P, Kjaer A. Angiogenesis PET/MRI predicts initial growth of sporadic vestibular schwannomas: a prospective study with follow-up in 29 patients using [68Ga]Ga-NODAGA-E[c(RGDyK)]2. EJNMMI Res. 2026 Jan 13;16(1):27. doi: 10.1186/s13550-025-01362-z. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009464 | Neuroma, Acoustic |
| ID | Term |
|---|---|
| D009442 | Neurilemmoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009463 | Neuroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D003390 | Cranial Nerve Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D010524 | Peripheral Nervous System Neoplasms |
| D000160 | Vestibulocochlear Nerve Diseases |
| D012181 | Retrocochlear Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010039 | Otorhinolaryngologic Neoplasms |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |