The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05996432
Recruitment Status : Recruiting
First Posted : August 18, 2023
Last Update Posted : August 18, 2023
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Jill De Vis, Vanderbilt-Ingram Cancer Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Head and Neck Squamous Cell Carcinoma Brain Metastases Procedure: Magnetic Resonance Imaging (MRI) Procedure: Positron Emission Tomography (PET) Drug: 18F-fluoromisonidazole Early Phase 1

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Non-invasive, Image-Based, In-Vivo Assessment of Tumor Hypoxia to Guide Hypoxia-Driven Adaptive Radiation Therapy
Actual Study Start Date : May 17, 2023
Estimated Primary Completion Date : November 30, 2026
Estimated Study Completion Date : May 31, 2029

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 Procedure: Magnetic Resonance Imaging (MRI)
Participants will undergo Magnetic Resonance Imaging

Procedure: Positron Emission Tomography (PET)
Participants will undergo Positron Emission Tomography

Drug: 18F-fluoromisonidazole
Given by IV
Experimental: Brain metastases
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)
Participants will undergo Magnetic Resonance Imaging

Procedure: Positron Emission Tomography (PET)
Participants will undergo Positron Emission Tomography

Drug: 18F-fluoromisonidazole
Given by IV


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 [ Time Frame: 1.5 years ]
    MRI assessed oxygen extraction fraction (OEF, %)


Secondary Outcome Measures :
  1. Assess treatment-related changes in tumor and peritumoral tissue oxygen consumption and perfusion via non-invasive MRI [ Time Frame: 4 years ]
    MRI assessed oxygen extraction fraction (OEF, %)


Other Outcome Measures:
  1. Evaluate the effect of pre-treatment and post-treatment tumor hypoxia on outcome [ Time Frame: 4 years ]
    Tumor recurrence

  2. Evaluate the effect of pre-treatment and post-treatment tumor hypoxia on outcome [ Time Frame: 4 years ]
    Radiation necrosis


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 </=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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05996432


Contacts
Layout table for location contacts
Contact: Vanderbilt-Ingram Services for Timely Access 800-811-8480 cip@vumc.org

Locations
Layout table for location information
United States, Tennessee
Vanderbilt University/Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37203
Contact: Vanderbilt-Ingram Service Services for Timely Access    800-811-8480    cip@vumc.org   
Principal Investigator: Jill De Vis, MD, PhD         
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Institutes of Health (NIH)
Investigators
Layout table for investigator information
Principal Investigator: Jill De Vis, MD, PhD Vanderbilt University/Ingram Cancer Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jill De Vis, Assistant Professor of Medicine, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT05996432    
Other Study ID Numbers: VICC-EDMDT23195
First Posted: August 18, 2023    Key Record Dates
Last Update Posted: August 18, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Neoplasms
Squamous Cell Carcinoma of Head and Neck
Hypoxia
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms, Respiratory
Head and Neck Neoplasms