A Phase 2 interventional study of One injection of 68Ga-NODAGA-E[c(RGDyK)]2 in Acoustic Neuroma, sponsored by Rigshospitalet, Denmark. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-01-10.
Sponsored by Rigshospitalet, Denmark · Phase 2, Interventional, and Diagnostic
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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).
100 studies on the registry are indexed under Neuroma, Acoustic; 28 are open to participants now.
This study's planned enrollment of 40 is above the median of 27 across 65 interventional studies indexed under Neuroma, Acoustic.
Browse Neuroma, Acoustic studies →Rigshospitalet, Denmark is the lead sponsor of 1,006 studies on the registry; 174 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
The radioligand 68Ga-NODAGA-E\[c(RGDyK)\]2 can be used as a prognostic marker for growth rate in patients with sporadic vestibular schwannomas.
Time frame: 1 hour
Started Jan 2018 (actual). Primary completion is estimated for Jan 2021, 36 months after the start.
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This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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