RGD PET/MRI in Sporadic Vestibular Schwannoma

Acoustic Neuroma Clinical Trial

Official title:

Kan tumorvækst Forudsiges Ved RGD-PET/MR af Vestibularis Schwannomer?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03393689
• Other study ID #: PCT2017-1
• Secondary ID: 2017-002604-27
• Status: Recruiting
• Phase: Phase 2
• First received: January 3, 2018
• Last updated: January 8, 2018
• Start date: January 2, 2018
• Est. completion date: January 2, 2021

Study information

• Verified date: January 2018
• Source: Rigshospitalet, Denmark
• Contact: Hjalte C.R. Sass, MD, Phd-fellow
• Phone: +45 31310730
• Email: hjalte.christian.reeberg.sass.01[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2, 2021
• Est. primary completion date: January 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acoustic Neuroma
• Neuroma
• Neuroma, Acoustic

Intervention

Drug:
• One injection of 68Ga-NODAGA-E[c(RGDyK)]2
One injection of 68Ga-NODAGA-E[c(RGDyK)]2

Locations

Country	Name	City	State
Denmark	Department of Otolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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