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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Brain metastases | Experimental | Participants will undergo magnetic resonance imaging (MRI) scans and positron emission tomography (PET) scans and administered the imaging agent 18F-fluoromisonidazole. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Procedure | Participants will undergo Magnetic Resonance Imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assess treatment-related changes in tumor and peritumoral tissue oxygen consumption and perfusion via non-invasive MRI | MRI assessed oxygen extraction fraction (OEF, %) | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effect of pre-treatment and post-treatment tumor hypoxia on outcome | Tumor recurrence | 4 years |
| Evaluate the effect of pre-treatment and post-treatment tumor hypoxia on outcome | Radiation necrosis |
Inclusion Criteria:
Exclusion Criteria:
Pregnant patients which will be identified as follows;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vanderbilt-Ingram Services for Timely Access | Contact | 800-811-8480 | cip@vumc.org |
| Name | Affiliation | Role |
|---|---|---|
| Evan Osmundson, MD, PhD | Vanderbilt University/Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University/Ingram Cancer Center | Recruiting | Nashville | Tennessee | 37203 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 18, 2024 | Jul 11, 2024 |
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| Positron Emission Tomography (PET) | Procedure | Participants will undergo Positron Emission Tomography |
|
| 18F-fluoromisonidazole | Drug | Given by IV |
|
| 4 years |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| C031843 | fluoromisonidazole |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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