Actively Recruiting
Image-Based, In-Vivo Assessment of Tumor Hypoxia to Guide Hypoxia-Driven Adaptive Radiation Therapy
Led by Vanderbilt-Ingram Cancer Center · Updated on 2024-09-23
48
Participants Needed
1
Research Sites
315 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt-Ingram Cancer Center
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Image-Based, In-Vivo Assessment of Tumor Hypoxia to Guide Hypoxia-Driven Adaptive Radiation Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of head and neck squamous cell carcinoma or brain metastases
- At least one measurable tumor lesion of 7 mm or larger by CT, MRI, or clinical exam
- ECOG performance status of 0 or 1 or Karnofsky score of 70% or higher
- Life expectancy over 6 months
- Agreement to use effective contraception before and after 18F-FMISO administration if of child-bearing potential
- Ability to understand and sign informed consent
You will not qualify if you...
- Allergy to compounds similar to 18F-FMISO
- Uncontrolled illness such as active infection, heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting study compliance
- Brain metastases larger than 3.0 cm
- Dural metastases suggestive of leptomeningeal disease
- Hemorrhage within the tumor lesion
- Receiving radiation after surgical removal of brain metastases or head and neck cancer
- History of brain diseases other than metastases, including stroke, brain hemorrhage, dementia, Parkinson's disease, multiple sclerosis, or schizophrenia
- Previous overlapping radiation treatments
- Unsuitable for MRI due to severe claustrophobia, presence of metal implants or devices, or weight over 350 pounds
- Other conditions that increase risk or limit study compliance
- Prisoners or children under 18 years
- Nursing women
- Refusal of pregnancy testing if under 60 years old
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37203
Actively Recruiting
Research Team
V
Vanderbilt-Ingram Services for Timely Access
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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