Brain Imaging Biomarkers in Patients With Brain Metastasis
ConditionBrain Metastases, Adult
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto
About this trial
A biomarker is a measurable indicator of the severity or presence of some disease state. In this study, brain metastases patients who will be receiving radiation treatment, will undergo CT (Computed Tomography) and MRI (Magnetic Resonance Imaging) scans prior to and after radiation treatment to measure these biomarkers. This is a single-center phase II study to validate the predictive abilities of biomarkers, in terms of determining how patients will respond to radiation treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Biopsy proven primary malignancy (original biopsy is adequate as long as the brain imaging is consistent with brain metastases)
At least one index lesion with diameter > 1cm and without imaging evidence of hemorrhage
Patients age > 18 years of age
Patients planned for RT to brain metastases
Disqualifiers
Previous Whole Brain Radiotherapy
Previous radiosurgery to the index lesion
Individuals unable to undergo contrasted MRI for whatever reason
Trial design
Design model
Single group
Treatments tested in this trial
CT and MRI Scans
Diagnostic testCT and MRI scans will occur before and after radiation therapy.
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: CT and MRI ScansOther 1 intervention
Trial outcomes
Primary outcomes
1
Response Assessment in Neuro-Oncology (RANO) to validate biomarkers
Using RANO to validate imaging predictive biomarkers of response to radiotherapy
Time frame
Up to 2 years.2
Response Evaluation Criteria in Solid Tumors (RECIST) criteria to validate biomarkers
Using RECIST criteria to validate imaging predictive biomarkers of response to radiotherapy
Time frame
Up to 2 years.3
Progression Free Survival (PFS) to validate biomarkers
Using PFS to validate imaging predictive biomarkers of response to radiotherapy
Time frame
Up to 2 years.Secondary outcomes
1
Objective (Radiological) Progression
Defined as increase in volume of contrast uptake on MRI of \> 25% as measured by two perpendicular tumor diameters compared to the smallest measurement ever for the same lesion by the same technique.
Time frame
Up to 2 years.2
Objective (Radiological) Response
Defined as stable or reduced volume of contrast uptake on MRI (i.e., all non-progression).
Time frame
Up to 2 years.3
Time to Intracranial Local Progression
Defined as the time interval between the date of first treatment and the date of objective radiological progression of any one of the treated lesions.
Time frame
Up to 2 years.4
Time to Intracranial Distant Progression
Defined as the time interval between the date of first treatment and the date of new brain metastases, with or without progression of the treated lesions.
Time frame
Up to 2 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov