Using advanced imaging to differentiate between true tumor progression and false alarms in brain cancer

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

This study is testing whether advanced imaging can help tell the difference between real brain cancer growth and false alarms in people being treated for gliomas.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT06199479 on ClinicalTrials.gov

What this trial studies

This study aims to determine if advanced imaging techniques can effectively distinguish true progression of brain malignancies from pseudoprogression, where the disease appears to worsen but has not. Participants with new suspicious imaging findings during glioma treatment will undergo high-quality MRI and stereotactic biopsy to correlate imaging results with tissue changes. The study will also explore the feasibility of using Contrast Clearance MR and Dual Energy CT imaging to enhance diagnostic accuracy. Additionally, it will gather data on clinical outcomes such as progression-free survival and overall survival.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old who have undergone prior treatment for a brain tumor and have new suspicious imaging findings requiring further diagnostic workup.

Not a fit: Patients with renal failure or those who do not meet the eligibility criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate diagnoses and treatment decisions for patients with brain malignancies.

How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for similar diagnostic challenges, suggesting potential success for this approach.

Eligibility criteria

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).

Where this trial is running

Houston, Texas

• MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Dawid Schellingerhout, MD — M.D. Anderson Cancer Center
• Study coordinator: Dawid Schellingerhout, MD

Conditions Brain Malignancies; Pseudoprogression