No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
90 (estimated)
Sponsor
Jona Hattangadi-Gluth · Other
Who this trial is looking for
This trial is looking for adults with brain metastases who want to participate in a new treatment to preserve cognitive function. If you join, you will undergo imaging tests and receive targeted radiation therapy.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older
I have one to three brain metastases smaller than 3 cm
I have a performance status of 0-2
I can follow commands during testing
I expect to live more than 6 months
I have confirmation of a cancerous tumor outside the brain
I am willing to have brain MRI scans
I can give informed consent
You may not be able to join if
I am pregnant or nursing
I am a woman of childbearing age and not using contraception
I cannot complete a MRI scan with contrast
My tumor is invading critical brain areas
I plan to have chemotherapy on the day of treatment
I have had whole brain radiation therapy before
I have leptomeningeal metastases
I have metastases from certain types of tumors like small cell carcinoma
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
In this proposal, the investigators introduce advanced diffusion and volumetric imaging techniques along with innovative, automated image parcellation methods to identify critical brain regions, incorporate into cognitive-sparing SRS for intracranial lesions, and analyze biomarkers of radiation response. This work will advance the investigators' understanding of neurocognitive changes after brain …
In this proposal, the investigators introduce advanced diffusion and volumetric imaging techniques along with innovative, automated image parcellation methods to identify critical brain regions, incorporate into cognitive-sparing SRS for intracranial lesions, and analyze biomarkers of radiation response. This work will advance the investigators' understanding of neurocognitive changes after brain SRS and help create interventions that preserve cognitive-function in patients with intracranial lesions.
Trial Locations
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Facility
City
State
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Status
Eligibility Criteria
Inclusion Criteria:
1. Patients 18 years or older
2. Eligible for intracranial SRS: Limited brain metastases targets geometrically feasible for SRS (intact or resected tumor bed), meningioma, or cerebral AVM
3. Eastern cooperative Oncology Group (ECOG) performance status 0-2 (score of 0, no symptom…
Inclusion Criteria:
1. Patients 18 years or older
2. Eligible for intracranial SRS: Limited brain metastases targets geometrically feasible for SRS (intact or resected tumor bed), meningioma, or cerebral AVM
3. Eastern cooperative Oncology Group (ECOG) performance status 0-2 (score of 0, no symptoms; 1, mild symptoms; 2, symptomatic, \<50% in bed during the day)
4. Ability to answer questions and follow commands via neurocognitive testing
5. Estimated life expectancy greater than 6 months
6. Pathologic confirmation of extracerebral tumor site (eg, lung, breast, prostate) from either the primary site or a metastatic lesion if brain metastasis
7. Willingness/Ability to undergo brain MRI scans
8. Able to give informed consent
Exclusion Criteria:
1. Pregnant or nursing women
2. Women of childbearing potential unwilling to use adequate contraception
3. Inability to complete a magnetic resonance imaging scan with contrast
4. Tumor directly invading the critical area to be spared (for example a patient with tumor invading a critical white matter tract; ineligible for cognitive-sparing)
5. Planned chemotherapy during SRS (on the day of SRS)
6. Previous whole brain radiation therapy
7. Leptomeningeal metastases (ineligible for SRS)
8. Metastases from primary germ cell tumor, small cell carcinoma, or primary CNS lymphoma (ineligible for SRS)
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