18F-AraG PET/CT as a Non-Invasive Imaging Biomarker for Chemoradiation Treatment Response in Esophageal Cancer

Inclusion Criteria:

1. Participants must be ≥18 years of age

2. Participants with locally advanced esophageal cancer

3. Participants with untreated documented carcinoma of the esophagus that is > 2 cm inpatients who are going to receive systemic therapy concurrently with radiation asprimary therapy are eligible

4. Ability to provide written informed consent in accordance with institutionalpolicies

5. Female participants of childbearing potential must have a negative serum or urinepregnancy test within 1 week of the proposed investigational PET/CT scan(s) prior toinjection of the investigational radiopharmaceutical

6. The effects of 18F-FAraG PET on the developing human fetus are unknown. For thisreason and because 18F-FAraG PET agents as well as other therapeutic agents used inthis trial are known to be teratogenic, women of child-bearing potential must agreeto use adequate contraception (hormonal or barrier method of birth control;abstinence) prior to study entry and for the duration of study participation. (Referto Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). Thisincludes all female participants, between the onset of menses (as early as 8 yearsof age) and 55 years unless the participant presents with an applicable exclusionaryfactor which may be one of the following:

• Postmenopausal (no menses in greater than or equal to 12 consecutive months).

• History of hysterectomy or bilateral salpingo-oophorectomy.

• Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausalrange, who have received Whole Pelvic Radiation Therapy).

• History of bilateral tubal ligation or another surgical sterilizationprocedure.

7. Approved methods of birth control are as follows: Hormonal contraception (i.e. birthcontrol pills, injection, implant, transdermal patch, vaginal ring), Intrauterinedevice (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy,Implantable or injectable contraceptives, and condoms plus spermicide. Not engagingin sexual activity for the total duration of the trial and the drug washout periodis an acceptable practice; however periodic abstinence, the rhythm method, and thewithdrawal method are not acceptable methods of birth control. Should a woman becomepregnant or suspect she is pregnant while she or her partner is participating inthis study, she should inform her treating physician immediately.

Exclusion Criteria:

1. Body weight ≥400 pounds or body habitus or disability that will not permit theimaging protocol to be performed

2. Pregnant or lactating females - Pregnant women are excluded from this study because 18F-FAraG PET agent with the potential for teratogenic or abortifacient effects.Because there is an unknown but potential risk for adverse events in nursing infantssecondary to treatment of the mother with [Agent], breastfeeding should bediscontinued if the mother is treated with [Agent]. These potential risks may alsoapply to other agents used in this study.

3. History of allergic reaction to intravenous contrast

4. eGFR<40 within 1 month prior to receiving 8F-FAraG