Acoustic NeuromaPhase 2NCT03393689
RGD PET/MRI in Sporadic Vestibular Schwannoma
A Phase 2 study testing One injection of 68Ga-NODAGA-E[c(RGDyK)]2 in people with Acoustic Neuroma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acoustic Neuroma
- What is being tested?
- One injection of 68Ga-NODAGA-E[c(RGDyK)]2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Jan 2018to 2 Jan 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Otolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet
Copenhagen, 2100
Hjalte C.R. Sass, MD, Ph.d.-fellow, +45 31310730, hjalte.christian.reeberg.sass.01@regionh.dk
Per Cayé-Thomasen, DMSci, Professor, +45 35452075, per.caye-thomasen.01@regionh.dk
About this study
Official title: Kan tumorvækst Forudsiges Ved RGD-PET/MR af Vestibularis Schwannomer?
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.
Read the 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).
- Conditions
- Acoustic Neuroma
- Being tested
- One injection of 68Ga-NODAGA-E[c(RGDyK)]2
- Keywords
- 68Ga-NODAGA-E[c(RGDyK)]2, Angiogenesis PET/MR, Acoustic Neuroma
- Medical subject headings
- Neuroma, Acoustic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One injection of 68Ga-NODAGA-E[c(RGDyK)]2Drug
One injection of 68Ga-NODAGA-E[c(RGDyK)]2
| Study group | Role | What they receive |
|---|---|---|
| Angiogenesis PET/MR | Experimental | One injection of the radioligand 68Ga-NODAGA-E[c(RGDyK)]2 followed by PET/MR Receives: Drug: One injection of 68Ga-NODAGA-E[c(RGDyK)]2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start2 Jan 2018
- Primary completion2 Jan 2021 (estimated)
- Study completion2 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acoustic NeuromaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hjalte Sass, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Hjalte C.R. Sass, MD, Ph.d.-Fellow, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393689
- Sponsor's protocol ID
- PCT2017-1
- Other IDs
- 2017-002604-27, 2017
- Status last verified
- Jan 2018
- First submitted
- 3 Jan 2018
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sass HCR, Jensen RG, Johannesen HH, Lofgren JO, Loft A, Andersen TL, Hansen AE, Caye-Thomasen P, Kjaer A. Angiogenesis PET/MRI predicts initial growth of sporadic vestibular schwannomas: a prospective study with follow-up in 29 patients using [68Ga]Ga-NODAGA-E[c(RGDyK)]2. EJNMMI Res. 2026 Jan 13;16(1):27. doi: 10.1186/s13550-025-01362-z.
PubMed 41530428
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kan tumorvækst Forudsiges Ved RGD-PET/MR af Vestibularis Schwannomer?
- ClinicalTrials.gov ID
- NCT03393689
- Acronym / sponsor ID
- PCT2017-1
- Conditions
- Acoustic Neuroma
- Keywords
- 68Ga-NODAGA-E[c(RGDyK)]2, Angiogenesis PET/MR, Acoustic Neuroma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 2 Jan 2021 (estimated)
- Study completion
- 2 Jan 2021 (estimated)
- First posted
- 8 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Angiogenesis PET/MR | Experimental | Drug: One injection of 68Ga-NODAGA-E[c(RGDyK)]2One injection of the radioligand 68Ga-NODAGA-E[c(RGDyK)]2 followed by PET/MR |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One injection of 68Ga-NODAGA-E[c(RGDyK)]2One injection of 68Ga-NODAGA-E[c(RGDyK)]2 | Drug | Angiogenesis PET/MR |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Derived from this study: PubMed 41530428Sass HCR, Jensen RG, Johannesen HH, Lofgren JO, Loft A, Andersen TL, Hansen AE, Caye-Thomasen P, Kjaer A. Angiogenesis PET/MRI predicts initial growth of sporadic vestibular schwannomas: a prospective study with follow-up in 29 patients using [68Ga]Ga-NODAGA-E[c(RGDyK)]2. EJNMMI Res. 2026 Jan 13;16(1):27. doi: 10.1186/s13550-025-01362-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hjalte C.R. Sass, MD, Ph.d.-Fellow principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing One injection of 68Ga-NODAGA-E[c(RGDyK)]2 in people with Acoustic Neuroma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hjalte C.R. Sass, MD, Phd-fellow (+45 31310730, hjalte.christian.reeberg.sass.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angiogenesis PET/MR imaging of patients with sporadic Vestibular Schwannomas (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03393689, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2018.