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RGD PET/MRI in Sporadic Vestibular Schwannoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03393689
Recruitment Status : Recruiting
First Posted : January 8, 2018
Last Update Posted : January 10, 2018
Information provided by (Responsible Party):
Hjalte Sass, Rigshospitalet, Denmark

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.

Condition or disease Intervention/treatment Phase
Acoustic Neuroma Drug: One injection of 68Ga-NODAGA-E[c(RGDyK)]2 Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03393689

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Contact: Hjalte C.R. Sass, MD, Phd-fellow +45 31310730
Contact: Andreas Kjær, DMSci, Phd, Professor +45 51724829

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Department of Otolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Hjalte C.R. Sass, MD, Ph.d.-fellow    +45 31310730   
Contact: Per Cayé-Thomasen, DMSci, Professor    +45 35452075   
Principal Investigator: Hjalte C.R. Sass, MD, Ph.d.-fellow         
Sponsors and Collaborators
Rigshospitalet, Denmark
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Principal Investigator: Hjalte C.R. Sass, MD, Ph.d.-Fellow Rigshospitalet, Denmark

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Responsible Party: Hjalte Sass, Principal Investigator, Rigshospitalet, Denmark Identifier: NCT03393689     History of Changes
Other Study ID Numbers: PCT2017-1
2017-002604-27 ( EudraCT Number )
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hjalte Sass, Rigshospitalet, Denmark:
Angiogenesis PET/MR
Acoustic Neuroma
Additional relevant MeSH terms:
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Neuroma, Acoustic
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Cranial Nerve Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Peripheral Nervous System Neoplasms
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Cranial Nerve Diseases
Nervous System Diseases