Brain Low-risk Aneurysm Stereotactic Radiosurgical Trial

NCT06047951 | Not Yet Recruiting

• 1 other identifier: 2022-4097
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to confirm the feasibility and safety of performing radiosurgery on unruptured, low-risk aneurysms in humans. Participants will choose if they want to undergo radiosurgery or not. Participants who choose not to have radiosurgery will be assigned to the observational group. Participants who choose to have radiosurgery performed will be assigned to the radiosurgery group. Participants in both groups will attend an initial exam session as well as four follow-up sessions: Day 0

• Initial questionnaire
• CTA scan
• MRI
• Radiosurgery performed on patients in the radiosurgery group 6 months
• CTA scan
• Follow-up questionnaire 12 months
• CTA scan
• MRI
• Follow-up questionnaire 24 months
• CTA scan
• Follow-up questionnaire 36 months
• CTA scan
• MRI
• Follow-up questionnaire Researchers will compare the observational group and the radiosurgery group to see if there is a difference in the incidence of aneurysm rupture during the study period (3 years). The hypothesis is that radiosurgery should not increase the risk of aneurysm rupture.

Conditions

Intracranial Aneurysm

Keywords

brain aneurysm, radiosurgery, intracranial aneurysm

Outcome Measures

Primary Outcomes (1)

• Between group difference in the incidence of aneurysm rupture during the study period

  The hypothesis is that SRS should not increase this risk.

  3 years from SRS

Secondary Outcomes (5)

• Incidence of any radiation-induced complications

  3 years

• Incidence of endovascular or surgical aneurysm treatment during the latency period

  3 years

• Change in aneurysm volume relative to baseline

  3 years

• Change in aneurysm shape indices relative to baseline

  3 years

• Aneurysm occlusion confirmed by CT-angiography (CTA)

  at 3 years from SRS

Study Arms (2)

SRS group

EXPERIMENTAL

Participants in the SRS group will receive the intervention described earlier, consisting of a Gamma Knife radiosurgery, and undergo the same follow-up exams (radiological and clinical) as participants of the control group.

Procedure: Stereotactic RadioSurgery (SRS)

Control group

NO INTERVENTION

The medical care will consist of observation for any element that may indicate an increased risk of rupture, like aneurysm growth or instability in shape.

Interventions

Stereotactic RadioSurgery (SRS) PROCEDURE

All treatments will be performed using the Gamma Knife Perfexion or Icon system (Elekta). The following treatment parameters will be used: * The head will be immobilized using a stereotactic Leksell Model G frame, installed using local protocols * Targeting will be performed by using a stereotactic CTA. No MRI will be performed. * Only one aneurysm will be treated per patient * The aneurysm, including its neck, will be contoured and targeted using a combination of 4mm isocenters as deemed appropriate by the treating team * A prescription dose of 25 Gy at the margin of the target will be used * The maximal dose on optic pathways will be kept below 10 Gy * The brainstem 12-Gy volume will be kept below 1cc

Also known as: Gamma Knife SRS

SRS group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical imaging (CTA, MRA or digital substraction angiography) reveals the existence of an asymptomatic unruptured saccular anterior circulation intracranial aneurysm under 7 mm
• Advised by a vascular neurosurgeon to observe rather than undergo endovascular or microsurgical management

You may not qualify if:

• Prior history of aneurysmal rupture
• Presence of symptoms that could be attributed to the aneurysm (severe headache, third cranial nerve deficits, or others)
• Imaging features deemed to increase rupture risk as evaluated by the treating physician
• Posterior circulation aneurysm
• Fusiform aneurysm
• Dissecting aneurysm
• Mycotic aneurysm
• Direct contact between the aneurysm and the optic pathways on medical imaging
• Prior coils or clips in the targeted aneurysm or any other aneurysm
• Patient unable to consent
• Patient unable or unlikely to comply with the follow-up schedule

Sponsors & Collaborators

• Dr David Mathieu: lead
• Université de Sherbrooke: collaborator
• Centre de recherche du Centre hospitalier universitaire de Sherbrooke: collaborator

Study Sites (1)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (25)

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• Erratum: Management of unruptured intracranial aneurysms. Neurol Clin Pract. 2014 Apr;4(2):98. doi: 10.1212/CPJ.0000000000000019.

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• Qureshi AI, Suri MF, Nasar A, Kirmani JF, Divani AA, He W, Hopkins LN. Trends in hospitalization and mortality for subarachnoid hemorrhage and unruptured aneurysms in the United States. Neurosurgery. 2005 Jul;57(1):1-8; discussion 1-8. doi: 10.1227/01.neu.0000163081.55025.cd.

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• Brisman JL, Song JK, Newell DW. Cerebral aneurysms. N Engl J Med. 2006 Aug 31;355(9):928-39. doi: 10.1056/NEJMra052760. No abstract available.

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• Molyneux AJ, Kerr RS, Yu LM, Clarke M, Sneade M, Yarnold JA, Sandercock P; International Subarachnoid Aneurysm Trial (ISAT) Collaborative Group. International subarachnoid aneurysm trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised comparison of effects on survival, dependency, seizures, rebleeding, subgroups, and aneurysm occlusion. Lancet. 2005 Sep 3-9;366(9488):809-17. doi: 10.1016/S0140-6736(05)67214-5.

  PMID: 16139655 BACKGROUND

• Wiebers DO, Whisnant JP, Huston J 3rd, Meissner I, Brown RD Jr, Piepgras DG, Forbes GS, Thielen K, Nichols D, O'Fallon WM, Peacock J, Jaeger L, Kassell NF, Kongable-Beckman GL, Torner JC; International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured intracranial aneurysms: natural history, clinical outcome, and risks of surgical and endovascular treatment. Lancet. 2003 Jul 12;362(9378):103-10. doi: 10.1016/s0140-6736(03)13860-3.

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• Froelich JJ, Neilson S, Peters-Wilke J, Dubey A, Thani N, Erasmus A, Carr MW, Hunn AW. Size and Location of Ruptured Intracranial Aneurysms: A 5-Year Clinical Survey. World Neurosurg. 2016 Jul;91:260-5. doi: 10.1016/j.wneu.2016.04.044. Epub 2016 Apr 20.

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• Starke RM, Kano H, Ding D, Lee JY, Mathieu D, Whitesell J, Pierce JT, Huang PP, Kondziolka D, Yen CP, Feliciano C, Rodgriguez-Mercado R, Almodovar L, Pieper DR, Grills IS, Silva D, Abbassy M, Missios S, Barnett GH, Lunsford LD, Sheehan JP. Stereotactic radiosurgery for cerebral arteriovenous malformations: evaluation of long-term outcomes in a multicenter cohort. J Neurosurg. 2017 Jan;126(1):36-44. doi: 10.3171/2015.9.JNS151311. Epub 2016 Mar 4.

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MeSH Terms

Conditions

Intracranial Aneurysm

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• David Mathieu, MD FRCS(C)

  Service de neurochirurgie, Département de chirurgie, Centre hospitalier universitaire de Sherbrooke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Mathieu, M.D. FRCS(C)

CONTACT

819-346-1110; david.mathieu@USherbrooke.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Division of Neurosurgery

Model Details: The study population will consist of adult men and women with a CTA-proven UIA under 7 mm who were advised to not undergo treatment because of its low rupture risk. The sample will consist of consecutively enrolled patients seen for a vascular neurosurgical consult or follow-up in the outpatient clinic of participating centers. All eligible patients will be offered to participate in the study at the next follow-up. Enrolled patients will then decide if they want to undergo SRS or if they prefer to continue being managed expectantly. Patients who decide to undergo SRS will be treated with radiosurgery according to the study protocol, while patients who decline SRS will be enrolled in a control, prospective, observational cohort with the same follow-up protocol as the SRS cohort. Furthermore, patients harbouring multiple UIAs will only be treated for one lesion. There will be no randomization or blinding.

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 21, 2023
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)