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Brain CancerNCT07512154

Precision Radiotherapy Enabled by Molecular MRI

A study testing Amide proton transfer radiotherapy and Standard radiotherapy in people with Brain Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Cancer
What is being tested?
Amide proton transfer radiotherapy and Standard radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
29 Apr 2026to May 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kristin Redmond contact

410-614-1642

kjanson3@jhmi.edu

United States1 site, 1 recruiting
  • Johns Hopkins University

    Baltimore, Maryland, 21287

    Dana B Kaplin, MPH, 410-614-3950, dkaplin1@jhmi.edu

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

Despite advances in therapy, glioblastoma remains almost universally fatal, with a high rate of local failure and a median survival of < 2 years. The standard of care for GBM is maximum safe surgical resection, followed by radiotherapy (RT) with temozolomide (TMZ) chemotherapy, which was established two decades ago. There is an urgent need to optimize each step of this standard therapy and develop new methods to fight this devastating disease. It is the infiltrative nature of GBM that limits resection and leads to suboptimal RT planning. To address this, neurosurgeons are employing supratotal resection, in which gadolinium-enhancing macroscopic tumor plus 1-2 cm extension into gadolinium-non-enhancing peritumoral regions is resected after preserving the highly eloquent region.

RT planning is complex and varies among medical centers, particularly in terms of inclusion of non-enhancing peritumoral regions in the clinical target volume. Moreover, lack of local therapy intensification of RT is considered one of the factors that prevent this standard therapy from achieving maximal tumor control. New RT approaches, such as focused dose escalation and proton therapy, require the best possible imaging methods to accurately visualize the extent of the tumor. Furthermore, standard structural MRI cannot distinguish between treatment effect from RT and tumor progression. Notably, the treated tumor may have progressed during fractionated RT, and the newly emerging active lesion could be missed from the original RT planning, particularly at the boost phase. New tissue-specific imaging approaches, like amide proton transfer (APT) imaging, that can accurately identify the tumor burden before, during, and after RT treatment are urgently needed.

The investigators central hypothesis in this highly innovative and clinically significant study is that protein-based APT-MRI is capable of identifying a precise high-protein tumor hotspot inside and outside Gd-enhancing regions with which to guide radiation dose escalation to high-risk active tumor and to facilitate an adaptive strategy to regions of therapeutic resistance during RT.

The innovative APT-RT technique developed by the investigators at Johns Hopkins enables a personalized RT regimen with precise dose escalation in high-risk tumor regions and response-adapted dose escalation in therapeutically resistant lesions in the boost phase, which could decrease the local recurrence rate. Personalized local therapy intensification would achieve maximal tumor control and improve the survival for GBM patients. The investigator's preliminary study will lay the foundation for a more definitive phase-II prospective clinical trial to assess the impact of APT imaging on RT guidance with regard to outcomes, including overall and progression-free survival, complications, toxicity, and quality of life. The investigators expect that APT-RT should be more effective for tumor control than the current conventional therapy.

Conditions
Brain Cancer
Being tested
Amide proton transfer radiotherapy, Standard radiotherapy
Keywords
Glioblastoma
Medical subject headings
Brain Neoplasms, Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Amide proton transfer radiotherapyRadiation

    Also called APT-RT

    New APT-RT regimen

  • Standard radiotherapyRadiation

    Also called RT

    Standard two-phase RT

Study groups in NCT07512154
Study groupRoleWhat they receive
Amide proton transfer radiotherapy (APT-RT)ExperimentalAmide 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.
Receives: Radiation: Amide proton transfer radiotherapy
Standard radiotherapy (RT)Active comparatorNot described
Receives: Radiation: Standard radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From baseline to 4 weeks post completion of RT.

Secondary outcomes (6)
  1. Overall survival

    Overall survival will be measured for each patient from randomization to the date of death.

    Measured: Randomization up to 2 years post completion of RT.

  2. Progression free survival

    Progression free survival will be measured for each patient from randomization to the date of progressive disease or death, whichever occurs first. The definition of progression will be based on RANO criteria.

    Measured: From randomization up to 2 years post completion of RT.

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

    All patients who receive any amount of RT will be evaluable for toxicity. CTCAE version 5 will be used to record grade 3 or greater neurologic toxicity.

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

  4. Radiation as assessed by grade 3 or greater neurologic toxicity

    All patients who receive any amount of RT will be evaluable for toxicity. RTOG/EORTC acute and late radiation morbidity score will be used to record grade 3 or greater neurologic toxicity.

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

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

    EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20) will be recorded for each patient. Score range 0-100. higher score, better quality of life. In case of disease progression within 2 years of cycle 1, patients will be re-tested for the final time only if previous assessment was >3 months from date of progression.

    Measured: 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.

  6. Quality of Life as assessed by the M. D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT)

    1. D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) will be recorded for each patient. Score ranges from 0 (best condition) to 10 (worst condition) In case of disease progression within 2 years of cycle 1, patients will be re-tested for the final time only if previous assessment was >3 months from date of progression.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2026
  2. Study start29 Apr 2026
  3. Primary completionMay 2031 (estimated)
  4. Study completionMay 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07512154
Sponsor's protocol ID
J2568
Other IDs
IRB00505816
Status last verified
May 2026
First submitted
30 Mar 2026
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Amide proton transfer radiotherapy and Standard radiotherapy in people with Brain Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kristin Redmond (410-614-1642, kjanson3@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in APTw signal (Efficacy of APT-RT) (time frame: From baseline to 4 weeks post completion of RT.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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