Precision Radiotherapy Enabled by Molecular MRI

NCT07512154 | Recruiting DMC

• 2 other identifiers: J2568IRB00505816
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Cancer

Keywords

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Change in APTw signal (Efficacy of APT-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.

  From baseline to 4 weeks post completion of RT.

Secondary Outcomes (6)

• Overall survival

  Randomization up to 2 years post completion of RT.

• Progression free survival

  From randomization up to 2 years post completion of RT.

• Toxicity and radiation as assessed by grade 3 or greater neurologic toxicity

  Baseline, Treatment weeks 1 - 6, Follow-ups: 6 month, 12 month, 24 month

• Radiation as assessed by grade 3 or greater neurologic toxicity

  Baseline, Treatment weeks 1 - 6, Follow-ups: 6 month, 12 month, 24 month

• Quality of Life as assessed by EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20)

  Baseline (≤21 days before starting RT), 1 month follow-up (≤10 days prior to cycle 1 of adjuvant TMZ), and every 6 months (+/- 1 month) up to 2 years from completion of RT.

Study Arms (2)

Amide proton transfer radiotherapy (APT-RT)

EXPERIMENTAL

Amide proton transfer radiotherapy (APT-RT) is weighted imaging that may enhance visualization of tumor infiltration and could reduce the risk of radiation toxicity while still effectively irradiating the tumor.

Radiation: Amide proton transfer radiotherapy

Standard radiotherapy (RT)

ACTIVE COMPARATOR

Radiation: Standard radiotherapy

Interventions

Amide proton transfer radiotherapy RADIATION

New APT-RT regimen

Also known as: APT-RT

Amide proton transfer radiotherapy (APT-RT)

Standard radiotherapy RADIATION

Standard two-phase RT

Also known as: RT

Standard radiotherapy (RT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• The Ben & Catherine Ivy Foundation: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms; Glioblastoma

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Kristin Redmond

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin Redmond

CONTACT

410-614-1642; kjanson3@jhmi.edu

Ryan Manuel

CONTACT

410-955-4261; rmanuel5@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open-label randomized pilot study. Patients will be randomized (1:1) to receive either standard RT (control) or APT-enhanced, dose-escalated adaptive RT (APT-RT), stratified by pre-RT tumor volume (small \<5 mL, moderate 5-20 mL, large \>20 mL).

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 6, 2026
• Study Start: April 29, 2026
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2032
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (1)