Trial Title:
Image-Based, In-Vivo Assessment of Tumor Hypoxia to Guide Hypoxia-Driven Adaptive Radiation Therapy
NCT ID:
NCT05996432
Condition:
Head and Neck Squamous Cell Carcinoma
Brain Metastases
Conditions: Official terms:
Brain Neoplasms
Squamous Cell Carcinoma of Head and Neck
Hypoxia
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging (MRI)
Description:
Participants will undergo Magnetic Resonance Imaging
Arm group label:
Brain metastases
Arm group label:
Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography (PET)
Description:
Participants will undergo Positron Emission Tomography
Arm group label:
Brain metastases
Arm group label:
Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Intervention type:
Drug
Intervention name:
18F-fluoromisonidazole
Description:
Given by IV
Arm group label:
Brain metastases
Arm group label:
Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Summary:
This study will apply novel MRI approaches with established sensitivity to tissue oxygen
consumption and perfusion to predict hypoxia-associated radiation resistance, manifested
as tumor recurrence and progression post-treatment.
Detailed description:
Primary Objective:
- To 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.
Secondary Objectives:
- To assess treatment-related changes in tumor and peritumoral tissue oxygen
consumption and perfusion via non-invasive MRI.
- To evaluate the effect of pre-treatment and post-treatment (3 months) tumor hypoxia
on tumor recurrence, progression, and radiation necrosis in patients with central
nervous system metastases treated with standard of care stereotactic radiosurgery.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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 /=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 Criteria:
- 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
Pregnant patients which will be identified as follows;
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Vanderbilt University/Ingram Cancer Center
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vanderbilt-Ingram Service Services for Timely Access
Phone:
800-811-8480
Email:
cip@vumc.org
Investigator:
Last name:
Evan Osmundson, MD, PhD
Email:
Principal Investigator
Start date:
May 17, 2023
Completion date:
May 31, 2029
Lead sponsor:
Agency:
Vanderbilt-Ingram Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Institutes of Health (NIH)
Agency class:
NIH
Source:
Vanderbilt-Ingram Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05996432
