NCT03393689

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2018

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 3, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2021

Completed
Last Updated

January 10, 2018

Status Verified

January 1, 2018

Enrollment Period

3 years

First QC Date

January 3, 2018

Last Update Submit

January 8, 2018

Conditions

Acoustic Neuroma

Keywords

68Ga-NODAGA-E[c(RGDyK)]2Angiogenesis PET/MRAcoustic Neuroma

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Angiogenesis PET/MR

EXPERIMENTAL

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

Interventions

One injection of 68Ga-NODAGA-E[c(RGDyK)]2DRUG

One injection of 68Ga-NODAGA-E\[c(RGDyK)\]2

Angiogenesis PET/MR

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Otolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Neuroma, Acoustic

Condition Hierarchy (Ancestors)

NeurilemmomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeuromaNerve Sheath NeoplasmsNeoplasms, Nerve TissueCranial Nerve NeoplasmsNervous System NeoplasmsNeoplasms by SitePeripheral Nervous System NeoplasmsVestibulocochlear Nerve DiseasesRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsCranial Nerve DiseasesNervous System Diseases

Study Officials

  • Hjalte C.R. Sass, MD, Ph.d.-Fellow

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hjalte C.R. Sass, MD, Phd-fellow

CONTACT

+45 31310730hjalte.christian.reeberg.sass.01@regionh.dk

Andreas Kjær, DMSci, Phd, Professor

CONTACT

+45 51724829andreas.kjaer@regionh.dk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 3, 2018

First Posted

January 8, 2018

Study Start

January 2, 2018

Primary Completion

January 2, 2021

Study Completion

January 2, 2021

Last Updated

January 10, 2018

Record last verified: 2018-01

Locations

DK(1)