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.
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.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Dana B Kaplin, MPH, 410-614-3950, dkaplin1@jhmi.edu
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Amide proton transfer radiotherapy |
| Standard radiotherapy (RT) | Active comparator | Not described Receives: Radiation: Standard radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
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.
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
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
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.
Quality of Life as assessed by the M. D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT)
- 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.
- First posted6 Apr 2026
- Study start29 Apr 2026
- Primary completionMay 2031 (estimated)
- Study completionMay 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Ben & Catherine Ivy Foundation
- Responsible party
- Sponsor
- Investigators
- Kristin Redmond, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Radiotherapy Enabled by Molecular MRI
- ClinicalTrials.gov ID
- NCT07512154
- Acronym / sponsor ID
- J2568
- Conditions
- Brain Cancer
- Keywords
- Glioblastoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- The Ben & Catherine Ivy Foundation
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- May 2031 (estimated)
- Study completion
- May 2032 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Amide proton transfer radiotherapy (APT-RT) | Experimental | Radiation: Amide proton transfer radiotherapyAmide 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. |
| Standard radiotherapy (RT) | Active comparator | Radiation: Standard radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- Patients of child-bearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amide proton transfer radiotherapyAlso: APT-RTNew APT-RT regimen | Radiation | Amide proton transfer radiotherapy (APT-RT) |
| Standard radiotherapyAlso: RTStandard two-phase RT | Radiation | Standard radiotherapy (RT) |
Primary outcome
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.
6 secondary outcomes
Overall survival
Time frame: Randomization up to 2 years post completion of RT.
Progression free survival
Time frame: From randomization up to 2 years post completion of RT.
Toxicity and radiation as assessed by grade 3 or greater neurologic toxicity
Time frame: Baseline, Treatment weeks 1 - 6, Follow-ups: 6 month, 12 month, 24 month
Radiation as assessed by grade 3 or greater neurologic toxicity
Time frame: 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)
Time frame: 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.
Quality of Life as assessed by the M. D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristin Redmond principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
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.