Recruiting

Early Phase 1

Adaptive Radiation TherapyImage-Based, In-Vivo Assessment of Tumor Hypoxia to Guide Hypoxia-Driven Adaptive Radiation Therapy

Sponsor:

Vanderbilt-Ingram Cancer Center

Code:

NCT05996432

Conditions

Head and Neck Squamous Cell Carcinoma

Brain Metastases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Magnetic Resonance Imaging (MRI)

Positron Emission Tomography (PET)

18F-fluoromisonidazole

Study Details

Brief 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.

Conditions

Head and Neck Squamous Cell Carcinoma

Brain Metastases

Study ID

NCT05996432

Start date

May 17, 2023

Status verified date

Sep, 2024

Completion date

May 31, 2029

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 </=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 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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Participants will undergo magnetic resonance imaging (MRI) scans and positron emission tomography (PET) scans and administered the imaging agent 18F-fluoromisonidazole.

experimental: Brain metastases

Participants will undergo magnetic resonance imaging (MRI) scans and positron emission tomography (PET) scans and administered the imaging agent 18F-fluoromisonidazole.

Interventions

Magnetic Resonance Imaging (MRI)

Participants will undergo Magnetic Resonance Imaging

Positron Emission Tomography (PET)

Participants will undergo Positron Emission Tomography

18F-fluoromisonidazole

Given by IV

Primary outcome measure

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 [ Time Frame: 1.5 years ]

Central Contacts and Locations

Central contacts

Vanderbilt-Ingram Services for Timely Access

800-811-8480 cip@vumc.org

Locations

Vanderbilt University/Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Vanderbilt-Ingram Service Services for Timely Access

800-811-8480 cip@vumc.org

Principal Investigator:

Evan Osmundson, MD, PhD

More Information

Sponsor

Vanderbilt-Ingram Cancer Center

Last update posted

Sep 23, 2024

Last verified

Sep, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt-Ingram Cancer Center on 2024-09-23.