Health TrialsbyHealthPanel

Brain Low-risk Aneurysm Stereotactic Radiosurgical Trial

ConditionIntracranial Aneurysm
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorDr David Mathieu

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stereotactic RadioSurgery (SRS)

    Procedure/Surgery

    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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: SRS groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

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.

Time frame
3 years from SRS

Secondary outcomes

1

Incidence of any radiation-induced complications

ex: brain edema, radiation necrosis

Time frame
3 years
2

Incidence of endovascular or surgical aneurysm treatment during the latency period

Number of patients undergoing treatment

Time frame
3 years
3

Change in aneurysm volume relative to baseline

Aneurysm volume in cubic millimeters (mm3) and dimensions in millimeters (mm) will be measured using segmentation facilities within the Osirix 6.5 software.

Time frame
3 years
4

Change in aneurysm shape indices relative to baseline

ex. Nonsphericity index, Aspect ratio, etc.

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr David Mathieu

Lead sponsor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Sponsor institution

Université de Sherbrooke

Collaborator

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: