Radiologic Pathologic Correlation of Imaging to Distinguish True Progression From Pseudoprogressi… (NCT06199479) | Clinical Trial Compass
RecruitingPhase 1
Radiologic Pathologic Correlation of Imaging to Distinguish True Progression From Pseudoprogression in Brain Malignancies
United States25 participantsStarted 2024-06-04
Plain-language summary
To learn if advanced imaging methods can tell apart true progression (the disease has actually gotten worse) from pseudoprogression (the disease appears to have gotten worse, but it actually has not).
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
. Participants is \>18 years old. The pediatric population has a different disease profile from adult glioma participants. To reduce heterogeneity in the patient population we will not consider participants younger than 18 for this study.
. The participants agrees to participate in the clinical study and to complete all required visits and evaluations.
. Participants has undergone prior treatment for a brain tumor and has a new suspicious imaging finding requiring diagnostic workup and is being considered for biopsy.
. Participants agrees to undergo, prior to the procedure, the needed imaging evaluation (within 14 days and preferably with 3 days of the planned procedure).
Exclusion criteria
. Renal failure as evidenced by a GFR of less than 30 mL/min/1.73m2 for gadolinium based imaging. In the absence of eGFR lab result, participants is not excluded in the absence of remarkable pathological renal history, as confirmed by and in the discretion of the PI.
. For iodinated contrast agent we will use the more strict cut-off of 45 mL/min/1.73m2 ((Davenport, Perazella et al. 2020), Consensus statement from the ACR and the National Kidney Foundation). The different threshold reflects the different risk profiles of these agents. Participants with GFR in the range 30-45 can receive a Non-Contrast DECT (CT contrast withheld).
. Pacemakers, electronic stimulation, metallic foreign bodies and devices and/or other conditions that are not MR safe, which include but are not limited to:
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
Safety and adverse events (AEs)
Timeframe: Through study completion; an average of 1 year
. Allergy to relevant imaging contrast agents, includes allergies to iodine or gadolinium-based contrast agents (if one class of agents is contra-indicated, then imaging with the other can still proceed).