Amide Proton Transfer Radiotherapy for Brain Tumor

Overseen By Ryan Manuel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Must not be taking: Investigational cancer agents

Disqualifiers: Pregnancy, Breastfeeding, Uncontrolled illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Kristin Redmond

Principal Investigator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Are You a Good Fit for This Trial?

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

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

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

How Is the Trial Designed?

Group I: Amide proton transfer radiotherapy (APT-RT) Experimental Treatment 1 Intervention

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.

Group II: Standard radiotherapy (RT) Active Control 1 Intervention

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+