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RecruitingNCT06199479Updated Jun 11, 2026

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

A Phase 1 interventional study of MRI Scan and CT Scan in Brain Malignancies and Pseudoprogression, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.

Sponsored by M.D. Anderson Cancer Center · Phase 1, Interventional, and Diagnostic

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 4 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

Read the detailed description

Primary Objectives To determine if advanced imaging findings can correlate with tissue changes in order to distinguish true progression from pseudoprogression. We will recruit participants with new suspicious enhancement developing during treatment for glioma, and systematically perform: a) high quality routine MR imaging (including routine, diffusion, permeability, perfusion and spectroscopy imaging as part of our regular ABTI protocol) and compare this imaging to b) pathology obtained by means of stereotactic biopsy. Pathology will serve as the gold standard to determine which imaging strategies are most successful in distinguishing between true Tumor recurrence and Pseudoprogression for each lesion.

Secondary Objectives

  1. To assess the feasibility of Contrast Clearance MR (delayed T1 enhanced MR) subtraction maps in distinguishing Pseudoprogression from true progression.
  2. To gather observational data for Dual Energy CT imaging and delayed contrast clearance with Dual Energy CT in the assessment of glioma.
  3. To correlate quantitative imaging biomarkers (derived from MR imaging data) along the biopsy tract with histological and clinical biomarkers. This exploratory data could generate novel comparisons to determine those imaging biomarkers that are most effective at predicting (a) cellular density and, (b) the types and relative numbers of cells present in the brain.
  4. To observe clinical outcomes such as progression free survival and overall survival in the trial population and relate these to imaging findings.
02

Conditions studied

  • Brain Malignancies
  • Pseudoprogression
03

In context

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Other
    Arm 1

    The tests and procedures done as part of your standard-of-care biopsy preparation, participants will also have advanced MRI and CT scans performed no later than 2 weeks before the biopsy. Typically, these scans are done within 1 or 2 days before surgery to provide the most accurate images to the surgeon.

    Procedure: MRI Scan · Procedure: CT Scan · Procedure: Biopsy

Interventions

  • ProcedureMRI Scan

    Performed by MRI Scan

  • ProcedureCT Scan

    Performed by CT Scan

  • ProcedureBiopsy

    Standard of Care Biopsy

06

What researchers measure

Primary outcomes

  1. Safety and adverse events (AEs)

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

    Time frame: Through study completion; an average of 1 year

07

Study locations

1 of 1 sites recruiting
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
    Recruiting
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06199479
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Jan 10, 2024
Start date
Jun 4, 2024
Primary completion
Oct 31, 2027 (estimated)
Completion
Oct 31, 2027 (estimated)
Last update
Jun 11, 2026

Study contacts

Dawid Schellingerhout, MD
Contact
dawid.schellingerhout@mdanderson.org
(713) 794-5673
Dawid Schellingerhout, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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