20 Participants NeededMy employer runs this trial

Amide Proton Transfer Radiotherapy for Brain Tumor

RM
Overseen ByRyan Manuel
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new MRI technique called amide proton transfer (APT) imaging to determine if it can better pinpoint aggressive areas in brain tumors for radiotherapy. The goal is to improve treatment accuracy and reduce side effects. Participants will receive either standard radiotherapy or the experimental APT-RT (Amide Proton Transfer Radiotherapy). Individuals diagnosed with glioblastoma or grade 4 astrocytoma who can undergo MRIs might be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future brain tumor treatments.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, you cannot be on any other investigational cancer treatment agents when you enroll.

What prior data suggests that this MRI technique is safe for identifying aggressive brain tumor areas?

Research has shown that amide proton transfer (APT) imaging is generally safe and well-tolerated by patients. APT imaging, a special type of MRI, helps doctors see brain tumors in detail. In past studies, patients experienced no significant side effects from APT imaging, indicating its safety in medical settings.

APT imaging has predicted certain features of brain tumors without harming patients. This technology allows doctors to understand and target tumors better without invasive procedures, potentially reducing the risk of unnecessary treatment side effects.

While the specific trial for APT radiotherapy is ongoing, the use of APT imaging in other studies suggests it is a safe and promising method to improve brain tumor treatment.12345

Why are researchers excited about this trial?

Amide proton transfer radiotherapy (APT-RT) is unique because it enhances the visualization of tumor infiltration in the brain, which might not be as clear with standard radiotherapy. This technique could potentially reduce the risk of radiation toxicity by targeting the tumor more precisely, sparing healthy tissue. Researchers are excited about APT-RT because it aims to balance effective tumor treatment with fewer side effects, offering a promising advancement in brain tumor care.

What evidence suggests that amide proton transfer radiotherapy is effective for brain tumors?

This trial will compare Amide Proton Transfer Radiotherapy (APT-RT) with standard radiotherapy (RT) for brain tumors. Research has shown that amide proton transfer (APT) imaging can identify the most aggressive parts of brain tumors. Studies have found that APT imaging distinguishes tumor tissue from other brain changes, such as swelling. This technique highlights areas with higher protein and peptide levels, often indicating increased tumor activity. In a study with 61 patients, APT imaging provided crucial information about brain tumors that guided treatment. It also enabled doctors to observe tumor responses to treatment earlier than usual methods.24678

Who Is on the Research Team?

KR

Kristin Redmond

Principal Investigator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Are You a Good Fit for This Trial?

This trial is for adults (over 18) with glioblastoma or grade 4 astrocytoma who have normal organ function and can safely get MRIs. Participants must not be pregnant, breastfeeding, or on other experimental cancer treatments, and must use birth control during the study.

Inclusion Criteria

My blood counts, liver, and kidney function are all within normal limits.
I am able to care for myself and do some daily activities.
Patients of child-bearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child
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Exclusion Criteria

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
Patients who are unable to receive MRIs will be excluded from the study
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive radiotherapy (RT) with temozolomide (TMZ) chemotherapy, including APT-RT for enhanced tumor visualization

6 weeks
Weekly visits for RT sessions

Follow-up

Participants are monitored for safety, effectiveness, and quality of life after treatment

24 months
Follow-ups at 1 month, 6 months, 12 months, and 24 months

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • Amide Proton Transfer Radiotherapy

Trial Overview

The study compares standard brain radiotherapy to a new approach that uses advanced MRI (amide proton transfer imaging) to target the most aggressive tumor areas more precisely. Patients are assigned based on their eligibility.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Amide proton transfer radiotherapy (APT-RT)Experimental Treatment1 Intervention
Group II: Standard radiotherapy (RT)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials
578
Recruited
33,600+

The Ben & Catherine Ivy Foundation

Collaborator

Trials
3
Recruited
100+

Citations

Performance of amide proton transfer imaging to differentiate ...

This meta-analysis identified a utility for APT-CEST imaging regarding the non-invasive discrimination of brain tumour progression from therapy-related changes.

Case Report Comparison of amide proton transfer imaging ...

This retrospective case series included 4 patients (5 lesions) with metastatic brain tumors who underwent both APT imaging and methionine PET for lesions ...

Innovative Value of Amide Proton Transfer Imaging in the ...

The results demonstrated that APT imaging effectively distinguished tumor tissue from edema by identifying elevated protein and peptide content ...

Amide Proton Transfer Radiotherapy for Brain Tumor

This is a research study to determine if a novel molecular magnetic resonance imaging (MRI) technique, called amide proton transfer (APT) ...

The Role of Amide Proton Transfer (APT)-Weighted ...

In this retrospective study of 61 patients with diffuse gliomas, APT-weighted imaging in the solid tumor component provided quantitative metrics associated ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39477835/

Amide proton transfer-weighted CEST MRI for radiotherapy ...

Conclusion: Larger biological GTVs compared to the conventional GTV highlight the potential of APT-weighted imaging for radiotherapy target ...

Amide proton transfer-weighted CEST MRI for radiotherapy ...

The introduction of APT-weighted imaging may, ultimately, enhance visualization of tumor infiltration and eliminate the need for the substantial ...

(PDF) Performance of amide proton transfer imaging to ...

This systematic review and meta-analysis elucidated the level of evidence and details of state-of-the-art imaging for APT-CEST in glioma and ...