Prediction of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage Using Dynamic 18F-FDG PET/CT (NCT04356599) | Clinical Trial Compass
CompletedNot Applicable
Prediction of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage Using Dynamic 18F-FDG PET/CT
France35 participantsStarted 2020-07-22
Plain-language summary
A pilot trial for assessing early microvascular alterations after aneurysmal subarachnoid hemorrhage using dynamic 18F-FDG PET/CT. The primary endpoint will be the measure of early changes in cerebral glucose uptake reflecting microperfusion.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* written informed consent to participate in the study must be obtained from the subject or proxy/legal representative prior to enrollment.
* males and females aged 18 years and older.
* SAH proven by computed tomography (CT) and that has occurred within the last 72 hours.
* ruptured saccular aneurysm angiographically confirmed by digital subtraction angiogram or CT angiogram, which has been successfully secured by surgical clipping or endovascular coiling.
* high-risk subjects for DCI: "thick clot" on the hospital admission CT (grade 3 or grade 4 on the modified Fisher Scale).
* a woman of childbearing potential is eligible only if the serum pregnancy test performed during the screening period is negative.
Exclusion Criteria:
* PET/CT contradications
* MRI contradications
* gadolinium or meglumine hypersensitivity
* glomerular filtration rate \<30mL/min
* SAH due to other causes than ruptured saccular aneurysm.
* post-HSA cardiac arrest.
* high sustained ICP ( \>20mmHg lasting \>20min) despite optimal treatment.
* significant and concomitant organ failure amongst the following: hypotension with systolic blood pressure \<90mmHg refractory to treatment; unresolved pulmonary edema or pneumonia with severe hypoxia defined as PaO2/FiO2 \<150; severe cardiac failure requiring inotropic support.
* patients with "do-not-resuscitate" orders, withdrawal of care situation, dying patient.
* vulnerable patient populations (minor, legal vulnerability, prisoner)
* pr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quantification of K1 parameter.
Timeframe: Day 2 +/- 1 day after the initial bleeding
2
Quantification of Ki parameter.
Timeframe: Day 2 +/- 1 day after the initial bleeding