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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT05996432
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Magnetic Resonance Imaging (MRI) — PROCEDURE
    Participants will undergo Magnetic Resonance Imaging
  • Positron Emission Tomography (PET) — PROCEDURE
    Participants will undergo Positron Emission Tomography
  • 18F-fluoromisonidazole — DRUG
    Given by IV

Study Details

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.

Key Dates

Start date
May 17, 2023
Status verified
Sep 2024
Primary completion
Nov 30, 2026
Completion
May 31, 2029

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

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

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37203
Vanderbilt-Ingram Service Services for Timely Access
[email protected]
800-811-8480
Evan Osmundson, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Nashville, TN

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Vanderbilt University/Ingram Cancer Center· Nashville, TN

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