Clinical Trial · NCT04846309

Hypoxia Imaging for Esophageal Cancer to Guide Personalized Radiation Therapy

Overview

This is a Phase I trial evaluating the safety of personalized radiation therapy based on levels of hypoxia identified on FMISO-PET and MRI. All patients will receive a baseline FMISO positron emission tomography (PET) and MRI to identify levels of hypoxia. Patients with tumor hypoxia will receive a higher dose of radiation therapy. Subjects who do not have hypoxic tumors will be treated with the standard-of-care radiation regimen. After fraction 10 of radiation therapy, an additional MRI will be performed. If this interim MRI demonstrates little or no response (as defined in Section 6), an optional boost radiation dose can be administered. Trial enrollment will be conducted in two parts. In Part 1, eight patients will be enrolled. After all eight patients have completed the 30 day dose-limiting toxicity (DLT) period, enrollment will be placed on hold and safety will be evaluated. During the interim analysis, one additional patient will be allowed to be enrolled in the trial. If the trial meets stopping rules as described in Section 11.3, the trial will be re-evaluated by the Data and Safety Monitoring Committee (DSMC) and the Principal Investigator. However, if the rate of DLTs remains below the unacceptable toxicity rate, enrollment will open to the enrollment of eight more patients.

Sponsor

University of Utah

Phase

Phase 1

Contacts

Shane Lloyd, MD (PRINCIPAL_INVESTIGATOR)

Rachel Kingsford (CONTACT)

rachel.kingsford@hci.utah.edu

801-585-0115

ClinicalTrials.gov

NCT04846309

Drug / Compound

FMISO

Isotope(s):

Target(s):

Hypoxia

Ligand Class: Small Molecules

Eligibility

Inclusion

Women \< 50 years of age:
* Male or female subject aged ≥ 18 years.
Esophageal cancer patient eligible to undergo either neoadjuvant or definitive chemoradiation therapy (CRT).Note: Stage IV patients with limited metastatic disease burden may be eligible if CRT is recommended by the multidisciplinary team.
For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.

Exclusion

The subject has severe, uncontrolled, significant intercurrent or recent illness that would exclude them from being a candidate for chemoradiation therapy.
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the radiation therapy are eligible for this trial.
Severe claustrophobia not amenable to pre-medication
* Unable to undergo an MRI for any reason, including:
Presence of metallic objects or implanted medical devices in the body that are not MRI-compatible (e.g., non-MRI-compatible cardiac pacemaker, deep brain stimulator, neurostimulator, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)