Using hypoxia imaging to personalize radiation therapy for esophageal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I trial evaluates the safety of personalized radiation therapy based on hypoxia levels identified through FMISO-PET and MRI in patients with esophageal cancer. Initially, all participants will undergo baseline imaging to assess tumor hypoxia. Those with hypoxic tumors will receive a higher radiation dose, while others will follow standard treatment. An interim MRI after 10 radiation fractions will help determine if additional radiation boosts are necessary based on treatment response.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
* 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:

  * Women \< 50 years of age:

    * Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
    * Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or
    * Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
  * Women ≥ 50 years of age:

    * Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
    * Had radiation-induced menopause with last menses \>1 year ago; or
    * Had chemotherapy-induced menopause with last menses \>1 year ago; or
    * Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
* Recovery to baseline or ≤ Grade 2 CTCAE v5 from toxicities related to any prior treatments, unless AE(s) are clinically non-significant and/or stable on supportive therapy.
* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

Exclusion Criteria:

* Unable to undergo an MRI for any reason, including:

  * Severe claustrophobia not amenable to pre-medication
  * 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)
* 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.
* The subject has severe, uncontrolled, significant intercurrent or recent illness that would exclude them from being a candidate for chemoradiation therapy.

  * Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
* Known HIV infection with a detectable viral load at the time of screening.

  * Note: Patients on effective antiretroviral therapy or who will plan on going on antiretroviral therapy at the time of screening are eligible for this trial. HIV testing is not required for eligibility.
* Known prior severe hypersensitivity to gadolinium, FMISO or any component in its formulations (NCI CTCAE v5.0 Grade ≥ 3).

Where it's running

• Huntsman Cancer Institute
  Salt Lake City, Utah, United States Recruiting

Study contacts

• Principal investigator: Shane Lloyd, MD — Huntsman Cancer Institute
• Study coordinator: Rachel Kingsford
• Email: rachel.kingsford@hci.utah.edu
• Phone: 801-585-0115

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.