Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2018-01-02
2021-01-02
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Angiogenesis PET/MR
One injection of the radioligand 68Ga-NODAGA-E\[c(RGDyK)\]2 followed by PET/MR
One injection of 68Ga-NODAGA-E[c(RGDyK)]2
One injection of 68Ga-NODAGA-E\[c(RGDyK)\]2
Interventions
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One injection of 68Ga-NODAGA-E[c(RGDyK)]2
One injection of 68Ga-NODAGA-E\[c(RGDyK)\]2
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Hjalte Sass
Principal Investigator
Principal Investigators
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Hjalte C.R. Sass, MD, Ph.d.-Fellow
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Department of Otolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet
Copenhagen, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2017-002604-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PCT2017-1
Identifier Type: -
Identifier Source: org_study_id
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