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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-11127 | Other Identifier | NCI-CTRP Clinical Registry |
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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).
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI Scan | Procedure | Performed by MRI Scan |
| |
| CT Scan |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and adverse events (AEs) | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Through study completion; an average of 1 year |
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Inclusion Criteria:
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:
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).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dawid Schellingerhout, MD | Contact | (713) 794-5673 | dawid.schellingerhout@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Dawid Schellingerhout, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D003581 | Cytodiagnosis |
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| Procedure |
Performed by CT Scan |
|
| Biopsy | Procedure | Standard of Care Biopsy |
|
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |