RGD PET/MRI in Sporadic Vestibular Schwannoma
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|ClinicalTrials.gov Identifier: NCT03393689|
Recruitment Status : Recruiting
First Posted : January 8, 2018
Last Update Posted : January 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acoustic Neuroma||Drug: One injection of 68Ga-NODAGA-E[c(RGDyK)]2||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Kan tumorvækst Forudsiges Ved RGD-PET/MR af Vestibularis Schwannomer?|
|Actual Study Start Date :||January 2, 2018|
|Estimated Primary Completion Date :||January 2, 2021|
|Estimated Study Completion Date :||January 2, 2021|
Experimental: Angiogenesis PET/MR
One injection of the radioligand 68Ga-NODAGA-E[c(RGDyK)]2 followed by PET/MR
Drug: One injection of 68Ga-NODAGA-E[c(RGDyK)]2
One injection of 68Ga-NODAGA-E[c(RGDyK)]2
- Angiogenesis PET/MR imaging of patients with sporadic Vestibular Schwannomas [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393689
|Contact: Hjalte C.R. Sass, MD, Phd-fellow||+45 email@example.com|
|Contact: Andreas Kjær, DMSci, Phd, Professor||+45 firstname.lastname@example.org|
|Department of Otolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet||Recruiting|
|Copenhagen, Denmark, 2100|
|Contact: Hjalte C.R. Sass, MD, Ph.d.-fellow +45 31310730 email@example.com|
|Contact: Per Cayé-Thomasen, DMSci, Professor +45 35452075 firstname.lastname@example.org|
|Principal Investigator: Hjalte C.R. Sass, MD, Ph.d.-fellow|
|Principal Investigator:||Hjalte C.R. Sass, MD, Ph.d.-Fellow||Rigshospitalet, Denmark|