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

Primary Purpose

Head and Neck Squamous Cell Carcinoma, Brain Metastases

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Magnetic Resonance Imaging (MRI)
Positron Emission Tomography (PET)
18F-fluoromisonidazole
Sponsored by
Vanderbilt-Ingram Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University/Ingram Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Brain metastases

Arm Description

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

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

Outcomes

Primary Outcome Measures

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, %)

Secondary Outcome Measures

Assess treatment-related changes in tumor and peritumoral tissue oxygen consumption and perfusion via non-invasive MRI
MRI assessed oxygen extraction fraction (OEF, %)

Full Information

First Posted
July 13, 2023
Last Updated
August 10, 2023
Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT05996432
Brief Title
Image-Based, In-Vivo Assessment of Tumor Hypoxia to Guide Hypoxia-Driven Adaptive Radiation Therapy
Official Title
Non-invasive, Image-Based, In-Vivo Assessment of Tumor Hypoxia to Guide Hypoxia-Driven Adaptive Radiation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2023 (Actual)
Primary Completion Date
November 30, 2026 (Anticipated)
Study Completion Date
May 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma, Brain Metastases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Arm Type
Experimental
Arm Description
Participants will undergo magnetic resonance imaging (MRI) scans and positron emission tomography (PET) scans and administered the imaging agent 18F-fluoromisonidazole.
Arm Title
Brain metastases
Arm Type
Experimental
Arm Description
Participants will undergo magnetic resonance imaging (MRI) scans and positron emission tomography (PET) scans and administered the imaging agent 18F-fluoromisonidazole.
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging (MRI)
Intervention Description
Participants will undergo Magnetic Resonance Imaging
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography (PET)
Intervention Description
Participants will undergo Positron Emission Tomography
Intervention Type
Drug
Intervention Name(s)
18F-fluoromisonidazole
Intervention Description
Given by IV
Primary Outcome Measure Information:
Title
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
Description
MRI assessed oxygen extraction fraction (OEF, %)
Time Frame
1.5 years
Secondary Outcome Measure Information:
Title
Assess treatment-related changes in tumor and peritumoral tissue oxygen consumption and perfusion via non-invasive MRI
Description
MRI assessed oxygen extraction fraction (OEF, %)
Time Frame
4 years
Other Pre-specified Outcome Measures:
Title
Evaluate the effect of pre-treatment and post-treatment tumor hypoxia on outcome
Description
Tumor recurrence
Time Frame
4 years
Title
Evaluate the effect of pre-treatment and post-treatment tumor hypoxia on outcome
Description
Radiation necrosis
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 </=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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanderbilt-Ingram Services for Timely Access
Phone
800-811-8480
Email
cip@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill De Vis, MD, PhD
Organizational Affiliation
Vanderbilt University/Ingram Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University/Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanderbilt-Ingram Service Services for Timely Access
Phone
800-811-8480
Email
cip@vumc.org
First Name & Middle Initial & Last Name & Degree
Jill De Vis, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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