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

NCT05996432 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: VICC-EDMDT23195
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

  MRI assessed oxygen extraction fraction (OEF, %)

  1.5 years

Secondary Outcomes (1)

• Assess treatment-related changes in tumor and peritumoral tissue oxygen consumption and perfusion via non-invasive MRI

  4 years

Other Outcomes (2)

• Evaluate the effect of pre-treatment and post-treatment tumor hypoxia on outcome

  4 years

• Evaluate the effect of pre-treatment and post-treatment tumor hypoxia on outcome

  4 years

Study Arms (2)

Locally Advanced Squamous Cell Carcinoma of the Head and Neck

EXPERIMENTAL

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

Procedure: Magnetic Resonance Imaging (MRI); Procedure: Positron Emission Tomography (PET); Drug: 18F-fluoromisonidazole

Brain metastases

EXPERIMENTAL

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

Procedure: Magnetic Resonance Imaging (MRI); Procedure: Positron Emission Tomography (PET); Drug: 18F-fluoromisonidazole

Interventions

Magnetic Resonance Imaging (MRI) PROCEDURE

Participants will undergo Magnetic Resonance Imaging

Brain metastases; Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Positron Emission Tomography (PET) PROCEDURE

Participants will undergo Positron Emission Tomography

Brain metastases; Locally Advanced Squamous Cell Carcinoma of the Head and Neck

18F-fluoromisonidazole DRUG

Given by IV

Brain metastases; Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37203, United States

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Brain Neoplasms

Interventions

Magnetic Resonance Spectroscopy; fluoromisonidazole

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Evan Osmundson, MD, PhD

  Vanderbilt University/Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanderbilt-Ingram Services for Timely Access

CONTACT

800-811-8480; cip@vumc.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiation Oncology

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: August 18, 2023
• Study Start: May 17, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): May 31, 2029
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

US (1)