Recruiting

APT Imaging

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Code:

NCT07512154

Conditions

Brain Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Amide proton transfer radiotherapy

Standard radiotherapy

Study Details

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

Study ID

NCT07512154

Start date

Apr 29, 2026

Status verified date

May, 2026

Completion date

May, 2032

Anticipated

Primary completion date

May, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Amide proton transfer radiotherapy (APT-RT)

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.

active comparator: Standard radiotherapy (RT)

Interventions

Amide proton transfer radiotherapy

New APT-RT regimen

Standard radiotherapy

Standard two-phase RT

Primary outcome measure

  • Change in APTw signal (Efficacy of APT-RT) [ Time Frame: From baseline to 4 weeks post completion of RT. ]

Central Contacts and Locations

Central contacts

Kristin Redmond

410-614-1642kjanson3@jhmi.edu

Ryan Manuel

410-955-4261rmanuel5@jhmi.edu

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Dana B Kaplin, MPH

410-614-3950dkaplin1@jhmi.edu

More Information

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

  • Glioblastoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins on 2026-05-06.