This phase I trial is to find out the side effects of personalized radiation therapy based on levels of tumor hypoxia (tumor cells have low oxygen) identified on FMISO-PET/CT and MRI in treating patients with esophageal cancer. PET portion of the scan uses radioactive imaging agents, called “tracers,” to look at the tumor so that physicians will have more information specific to the tumor. [18F]FMISO is a tracer used to look at how much oxygen is in the tumor. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Diagnostic procedures such as [18F]FMISO PET/CT may help researchers better identify the dose of radiation treatment needed for individual tumors.
Additional locations may be listed on ClinicalTrials.gov for NCT04846309.
Locations matching your search criteria
United States
Utah
Salt Lake City
Huntsman Cancer Institute/University of UtahStatus: Active
Contact: Shane Lloyd
Phone: 801-585-0255
PRIMARY OBJECTIVE:
I. To assess the safety and tolerability of using hypoxia positron emission tomography (PET)/ computed tomography (CT) imaging with fluorine-18 fluoromisonidazole (FMISO) and magnetic resonance imaging (MRI) measures of radioresistance to personalize radiation therapy by delivering a higher dose of radiation to hypoxic tumors.
SECONDARY OBJECTIVE:
I. To assess the efficacy of hypoxia imaging-guided radiation treatment.
EXPLORATORY OBJECTIVES:
I. To assess the baseline FMISO PET uptake and whether they match MRI parameters of hypoxia.
II. To assess the imaging markers of hypoxia and radioresistance on FMISO PET and MRI with clinical and pathologic response to chemoradiation therapy and progression free survival (PFS).
III. As available, to discover blood-based biomarkers of radiation sensitivity and whether they are associated with response to chemoradiation therapy or PFS.
IV. Compare the toxicity outcomes between the patients receiving photon versus (vs) proton therapy.
OUTLINE:
Patients receive [18F]FMISO intravenously (IV) and undergo PET/CT and MRI at baseline. Patients identified as having hypoxic tumors, undergo higher dose radiation therapy on 5 consecutive days every week for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients who do not have hypoxic tumors undergo standard of care radiation therapy. After fraction 10 of radiation therapy, patients undergo an additional MRI. Patients with little or no response on interim MRI, may undergo boost radiation therapy. Patients additionally undergo blood sample collection and PET/CT or CT throughout study.
After completion of study treatment, patients are followed up at 30 and 84 days, then every 3 months for up to 18 months.
Lead OrganizationHuntsman Cancer Institute/University of Utah
Principal InvestigatorShane Lloyd