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
Apply to this trial

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

First listed
Aug 18, 2023
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

Related Studies