Back to resultsRGD PET/MRI in Sporadic Vestibular Schwannoma
Primary Purpose
Acoustic Neuroma
Status
Unknown status
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
One injection of 68Ga-NODAGA-E[c(RGDyK)]2
Sponsored by
About this trial
This is an interventional diagnostic trial for Acoustic Neuroma focused on measuring 68Ga-NODAGA-E[c(RGDyK)]2, Angiogenesis PET/MR, Acoustic Neuroma
Eligibility Criteria
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.
Sites / Locations
- Department of Otolaryngology, Head and Neck Surgery & Audiology, RigshospitaletRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Angiogenesis PET/MR
Arm Description
One injection of the radioligand 68Ga-NODAGA-E[c(RGDyK)]2 followed by PET/MR
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03393689
First Posted
January 3, 2018
Last Updated
January 8, 2018
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT03393689
Brief Title
RGD PET/MRI in Sporadic Vestibular Schwannoma
Official Title
Kan tumorvækst Forudsiges Ved RGD-PET/MR af Vestibularis Schwannomer?
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
January 2, 2021 (Anticipated)
Study Completion Date
January 2, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acoustic Neuroma
Keywords
68Ga-NODAGA-E[c(RGDyK)]2, Angiogenesis PET/MR, Acoustic Neuroma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Angiogenesis PET/MR
Arm Type
Experimental
Arm Description
One injection of the radioligand 68Ga-NODAGA-E[c(RGDyK)]2 followed by PET/MR
Intervention Type
Drug
Intervention Name(s)
One injection of 68Ga-NODAGA-E[c(RGDyK)]2
Intervention Description
One injection of 68Ga-NODAGA-E[c(RGDyK)]2
Primary Outcome Measure Information:
Title
Angiogenesis PET/MR imaging of patients with sporadic Vestibular Schwannomas
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hjalte C.R. Sass, MD, Phd-fellow
Phone
+45 31310730
Email
hjalte.christian.reeberg.sass.01@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Kjær, DMSci, Phd, Professor
Phone
+45 51724829
Email
andreas.kjaer@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hjalte C.R. Sass, MD, Ph.d.-Fellow
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Otolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hjalte C.R. Sass, MD, Ph.d.-fellow
Phone
+45 31310730
Email
hjalte.christian.reeberg.sass.01@regionh.dk
First Name & Middle Initial & Last Name & Degree
Per Cayé-Thomasen, DMSci, Professor
Phone
+45 35452075
Email
per.caye-thomasen.01@regionh.dk
First Name & Middle Initial & Last Name & Degree
Hjalte C.R. Sass, MD, Ph.d.-fellow
12. IPD Sharing Statement
Learn more about this trial
RGD PET/MRI in Sporadic Vestibular Schwannoma
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