Radiologic Pathologic Correlation of Imaging to Distinguish True Progression From Pseudoprogression in Brain Malignancies

Trial ID: NCT06199479

Interventional - Phase 1 - Recruiting

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).

Conditions

• Brain Malignancies
• Pseudoprogression

Interventions

• MRI Scan
• CT Scan
• Biopsy

Eligibility

Inclusion criteria

• 1. 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.
• 2. The participants agrees to participate in the clinical study and to complete all required visits and evaluations.
• 3. 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.
• 4. 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

• 1. 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.
• 2. 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).
• 3. Pacemakers, electronic stimulation, metallic foreign bodies and devices and/or other conditions that are not MR safe, which include but are not limited to:
• electronically, magnetically, and mechanically activated implants
• ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators and cardiac pacemakers
• metallic splinters in the eye
• ferromagnetic hemostatic clips in the central nervous system (CNS) or body
• cochlear implants
• other pacemakers, e.g., for the carotid sinus
• insulin pumps and nerve stimulators
• non-MR safe lead wires
• prosthetic heart valves (if dehiscence is suspected)
• non-ferromagnetic stapedial implants
• pregnancy
• claustrophobia that does not readily respond to oral medication.
• Nonetheless, if patients have an electronic device for which manufacturer's guidelines exist to permit safe MR scanning (such as the Cardiology supervised pacemaker scanning program), such a patient would still be eligible to participate in the trial. Such patients will be scanned as per manufacturers recommendations.
• 4. 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).

Sponsor

M.D. Anderson Cancer Center

Source: ClinicalTrials.gov

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