Image-Based Assessment of Tumor Hypoxia for Adaptive Radiation Therapy
This study is looking at new ways to use imaging to understand oxygen levels in tumors for people with head and neck squamous cell carcinoma or brain metastases (cancer that has spread to the brain). You would undergo Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) scans, and receive a drug called 18F-fluoromisonidazole intravenously (through a vein). The main goal is to see if non-invasive MRI scans can accurately show tumor hypoxia (low oxygen levels in the tumor), which is also identified by the 18F-FMISO-PET-CT scans. This study aims to enroll 48 participants and is currently unclear on its recruitment status.
- Study design
- This is an interventional study, meaning participants will receive specific procedures. It plans to enroll 48 participants.
- What's involved
- You would undergo Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) scans, and receive 18F-fluoromisonidazole intravenously.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at 1.5 years, and secondary objectives evaluate effects at 3 months post-treatment.
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NCT05996432
Image-Based, In-Vivo Assessment of Tumor Hypoxia to Guide Hypoxia-Driven Adaptive Radiation Therapy
Recruiting
EARLY_PHASE1Ages 18+InterventionalDiagnosticVanderbilt-Ingram Cancer CenterInvestigator-initiated
~48 participants
Updated 2024-09-23 on ClinicalTrials.gov
What's tested:Magnetic Resonance Imaging (MRI)Positron Emission Tomography (PET)18F-fluoromisonidazole
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Validate non-invasive, MRI-based markers of tumor hypoxia in patients with brain metastases or head and neck cancer with and without evidence of tumor hypoxia identified by 18F-FMISO-PET-CT
Measured over 1.5 years
Conditions
Where it's being run
1 sites across 1 statesTennessee1
Study leadership
- Evan Osmundson, MD, PhD · PRINCIPAL_INVESTIGATOR · Vanderbilt University/Ingram Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Histologically or cytologically confirmed head and neck squamous cell carcinoma or a clinical diagnosis of CNS-excluded nervous system neoplasm and disorder (brain metastases)
Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions, minimum size 7mm) with CT scan, MRI, or calipers by clinical exam
ECOG performance status \</=1 Karnofsky \>/=70%
Life expectancy of greater than 6 months
The effects of 18F-FMISO on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and up until the day after 18F-FMISO administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception on the days of 18F-FMISO administration
Ability to understand and the willingness to sign a written informed consent document
Exclusion
History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FMISO
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
Brain metastases \>3.0 cm
Dural-based metastases concerning for leptomeningeal disease
Hemorrhage within the lesion of interest
Patients presenting for radiation after surgical resection of brain metastasis/metastases or primary head and neck cancer (adjuvant radiotherapy)
Prior or current known history of disease involving the brain other than brain metastases and including but not limited to; cerebrovascular disease (i.e., stroke or large vessel disease), brain hemorrhage (i.e., subarachnoid hemorrhage or intraparenchymal hemorrhage), Alzheimer's disease or dementia, Parkinson's disease, Multiple Sclerosis or schizophrenia
Prior overlapping radiation fields
Not suitable to undergo MRI because of; severe claustrophobia, presence of metallic objects or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the imaging site, or steel implants)
Presence of any other co-existing condition which, in the judgment of the investigator, might increase the risk to the subject
Presence of serious systemic illness, including uncontrolled intercurrent infection or psychiatric/social situations which may limit compliance with study requirements
Not suitable to undergo MRI, including weight greater than 350lbs (common weight limit for the MRI table)
Prisoners, children \<18 years of age
Prior overlapping radiation fields
Not suitable to undergo MRI because of; severe claustrophobia, presence of metallic objects or implanted medical devices in body (i.e., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the imaging site, or steel implants)
Presence of any other co-existing condition which, in the judgment of the investigator, might increase the risk to the subject
Presence of serious systemic illness, including uncontrolled intercurrent infection or psychiatric/social situations which may limit compliance with study requirements
Not suitable to undergo MRI, including weight greater than 350lbs (common weight limit for the MRI table)
Prisoners, children \<18 years of age
The effects of 18F-FMISO on the developing infant are unknown. For this reason, nursing women will be excluded from the trial
Patients over the age of 60 do not require a pregnancy test per institutional guidelines. We anticipate this to be most of our patient population due to the age distribution of cancer patients.
Patients under the age of 60 will be offered a point of care pregnancy test when seen in consult at the department of Radiation Oncology.
Patients refusing pregnancy testing can sign a waiver stating that they refuse pregnancy testing but that they are not known to be pregnant
What this trial measures
- Validate non-invasive, MRI-based markers of tumor hypoxia in patients with brain metastases or head and neck cancer with and without evidence of tumor hypoxia identified by 18F-FMISO-PET-CT1.5 years
MRI assessed oxygen extraction fraction (OEF, %)