Precision radiotherapy guided by molecular MRI (APT imaging)
Precision Radiotherapy Enabled by Molecular MRI
This project will test whether a special MRI scan called amide proton transfer (APT) imaging can better identify the most aggressive areas of glioblastoma to guide radiotherapy in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT07512154 on ClinicalTrials.gov |
What this trial studies
The trial uses APT molecular MRI to map biochemical signals within glioblastoma and to identify potentially more aggressive tumor regions not seen on standard MRI. Radiotherapy plans guided by APT imaging will be compared with standard radiotherapy planning, with patients receiving concurrent temozolomide per standard care. Eligible adults with histologically confirmed glioblastoma or grade 4 astrocytoma and adequate organ function must be able to undergo MRI. Imaging and treatment are performed at Johns Hopkins with follow-up scans to monitor response and to help distinguish tumor progression from treatment effects.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed glioblastoma or grade 4 astrocytoma, KPS ≥60, adequate organ and marrow function, able to undergo MRI, not receiving other investigational cancer agents, and willing to use contraception if of child-bearing potential are ideal candidates.
Not a fit: Patients who cannot have MRIs, those on other investigational cancer therapies, or those with poor performance status (KPS <60) are unlikely to be eligible or to benefit from this approach.
Why it matters
Potential benefit: If successful, APT-guided radiotherapy could allow more accurate targeting of aggressive tumor regions, potentially improving local tumor control while sparing healthy brain.
How similar studies have performed: Early research using APT and other molecular MRI techniques has shown promise in detecting active tumor regions and distinguishing tumor from treatment effect, but APT-guided radiotherapy remains largely experimental without large randomized confirmation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologic confirmation of glioblastoma or grade 4 astrocytoma * Age \>18 * 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 this trial is running
Baltimore, Maryland
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Kristin Redmond — Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Study coordinator: Kristin Redmond
- Email: kjanson3@jhmi.edu
- Phone: 410-614-1642
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.