NCT05996432

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

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: * To assess treatment-related changes in tumor and peritumoral tissue oxygen consumption and perfusion via non-invasive MRI. * To evaluate the effect of pre-treatment and post-treatment (3 months) tumor hypoxia on tumor recurrence, progression, and radiation necrosis in patients with central nervous system metastases treated with standard of care stereotactic radiosurgery.

Conditions

• Head and Neck Squamous Cell Carcinoma
• Brain Metastases

Interventions

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

Timeline

• Start date: 2023-05-17
• Primary completion: 2026-11-30
• Completion: 2029-05-31
• First posted: 2023-08-18
• Last updated: 2024-09-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study