NCT07512154 · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Precision Radiotherapy Enabled by Molecular MRI
What this study is about
This is a research study to determine if a novel molecular magnetic resonance imaging (MRI) technique, called amide proton transfer (APT) imaging, is useful in identifying the most aggressive areas of tumor needed for radiotherapy of brain tumors.
View original scientific description
This is a research study to determine if a novel molecular magnetic resonance imaging (MRI) technique, called amide proton transfer (APT) imaging, is useful in identifying the most aggressive areas of tumor needed for radiotherapy of brain tumors.
Interventions
RADIATION
Amide proton transfer radiotherapy
New APT-RT regimen
RADIATION
Standard radiotherapy
Standard two-phase RT
Primary outcome measures
Change in APTw signal (Efficacy of APT-RT)
Time frame: From baseline to 4 weeks post completion of RT.
A reduction in APTw signal following treatment suggests a positive response to therapy (active tumor APTw = 3-4% vs. necrosis/no tumor APTw 1-2%). A 1% greater reduction in mean APTw signal change within the Gd-enhancing tumor region from baseline (pre-RT) to post-RT in the APT-RT arm, compared to the control arm.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Histologic confirmation of glioblastoma or grade 4 astrocytoma
- KPS at least 60
- Patients must have normal organ and marrow function as defined below:
- leukocytes \>3,000/mcL
- absolute neutrophil count \>1,500/mcL
- platelets \>100,000/mcL
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) \<2.5
- institutional upper limit of normal
- creatinine within normal institutional limits OR creatinine clearance \>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- Patients of child-bearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
- Patients who are unable to receive MRIs will be excluded from the study.
- Patients may not be receiving any other investigational cancer treatment agents at the time of enrollment.
- Patients may not have previously been treated with an overlapping course of radiotherapy to the brain.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant and/or breastfeeding women are excluded. Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and up to 12 weeks after the study are excluded. Male subjects must also agree to use effective contraception for the same period as above.
Where
- Baltimore, Maryland
Collaborators
The Ben & Catherine Ivy Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 6, 2026 · Source of record for eligibility and locations