Recruiting

Advanced Imaging for Progression vs. Pseudoprogression in Brain Cancer

Study Aim

This study aims to evaluate the safety of advanced imaging techniques to distinguish between actual progression and pseudoprogression in brain cancer patients.

What is being tested

MRI Scan

+ CT Scan

+ Biopsy

Procedure

Who is being recruted

Over 18 Years

+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Diagnostic Study

Phase 1

Interventional

Study Start: June 2024

See protocol details

Summary

Principal SponsorM.D. Anderson Cancer Center

Study ContactDawid Schellingerhout, MD

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 4, 2024

Actual date on which the first participant was enrolled.

This clinical trial focuses on improving the ability to tell the difference between true tumor growth and pseudoprogression in people undergoing treatment for a type of brain cancer called glioma. Pseudoprogression can appear similar to tumor growth on regular scans, but it is actually just a temporary reaction to treatment. This research aims to find out if advanced imaging techniques can match up with actual tissue changes in the brain, using a detailed comparison between images and tissue samples. This is important because accurately distinguishing between these two conditions can help doctors make better treatment decisions, potentially leading to more effective care for patients with glioma. Participants in this study will undergo various high-quality MRI scans as part of their regular care, and these images will be compared to tissue samples taken through a precise biopsy method. The study will analyze how well these advanced imaging techniques, including diffusion, permeability, perfusion, and spectroscopy imaging, can identify true tumor growth versus pseudoprogression. Additionally, the study explores the potential of advanced MRI and CT techniques to provide further insights. Researchers will also examine how certain imaging features correlate with clinical outcomes, such as survival rates, to improve future treatment planning for patients with brain cancer.

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

NCT06199479

Principal SponsorM.D. Anderson Cancer Center

Study ContactDawid Schellingerhout, MD

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

25 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate

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).

4 exclusion criteria prevent from participating

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: * 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.

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).

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

MD Anderson Cancer Center

Houston, United StatesOpen MD Anderson Cancer Center in Google Maps

Recruiting

One Study Center