Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT05996432

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States, 37203

Actively Recruiting

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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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