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Precision Radiotherapy Enabled by Molecular MRI

ConditionBrain Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologic confirmation of glioblastoma or grade 4 astrocytoma

Age >18

KPS at least 60

leukocytes >3,000/mcL

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Amide proton transfer radiotherapy

    Radiation

    New APT-RT regimen

  • Standard radiotherapy

    Radiation

    Standard two-phase RT

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Amide proton transfer radiotherapy (APT-RT)Experimental treatment 1 intervention
Group B: Standard radiotherapy (RT)Active comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
From baseline to 4 weeks post completion of RT.

Secondary outcomes

1

Overall survival

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

Time frame
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.

Time frame
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.

Time frame
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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead sponsor

The Ben & Catherine Ivy Foundation

Collaborator

Source ClinicalTrials.gov
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