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Head and Neck Squamous Cell CarcinomaEarly Phase 1NCT05996432

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

A Early Phase 1 study testing Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET) and 18F-fluoromisonidazole in people with Head and Neck Squamous Cell Carcinoma and Brain Metastases, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET) and 18F-fluoromisonidazole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
17 May 2023to 31 May 2029
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 24Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Vanderbilt-Ingram Services for Timely Access contact

800-811-8480

cip@vumc.org

United States1 site, 1 recruiting

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37203

    Vanderbilt-Ingram Service Services for Timely Access, 800-811-8480, cip@vumc.org

    Evan Osmundson, MD, PhD

    Recruiting

Other trials in United States

About this study

Official title: Non-invasive, Image-Based, In-Vivo Assessment of Tumor Hypoxia to Guide Hypoxia-Driven Adaptive Radiation Therapy

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.

Read the 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.
Being tested
Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET), 18F-fluoromisonidazole
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnetic Resonance Imaging (MRI)Procedure or surgery

    Participants will undergo Magnetic Resonance Imaging

  • Positron Emission Tomography (PET)Procedure or surgery

    Participants will undergo Positron Emission Tomography

  • 18F-fluoromisonidazoleDrug

    Given by IV

Study groups in NCT05996432
Study groupRoleWhat they receive
Locally Advanced Squamous Cell Carcinoma of the Head and NeckExperimentalParticipants will undergo magnetic resonance imaging (MRI) scans and positron emission tomography (PET) scans and administered the imaging agent 18F-fluoromisonidazole.
Receives: Procedure: Magnetic Resonance Imaging (MRI); Procedure: Positron Emission Tomography (PET); Drug: 18F-fluoromisonidazole
Brain metastasesExperimentalParticipants will undergo magnetic resonance imaging (MRI) scans and positron emission tomography (PET) scans and administered the imaging agent 18F-fluoromisonidazole.
Receives: Procedure: Magnetic Resonance Imaging (MRI); Procedure: Positron Emission Tomography (PET); Drug: 18F-fluoromisonidazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  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, %)

    Measured: 1.5 years

Secondary outcomes (1)

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

    MRI assessed oxygen extraction fraction (OEF, %)

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2023
  2. Study start17 May 2023
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion31 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05996432
Sponsor's protocol ID
VICC-EDMDT23195
Status last verified
Sep 2024
First submitted
13 Jul 2023
Last updated
23 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET) and 18F-fluoromisonidazole in people with Head and Neck Squamous Cell Carcinoma and Brain Metastases, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vanderbilt-Ingram Services for Timely Access (800-811-8480, cip@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05996432.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.

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