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Imaging Biomarker for Esophageal Cancer

Phase < 1

Recruiting

Led By Steven Lin, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be ≥18 years of age

Participants with locally advanced esophageal cancer

Must not have

Body weight ≥400 pounds or body habitus or disability that will not permit the imaging protocol to be performed

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year.

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if a special type of PET scan can detect tumors in people with esophageal cancer and predict how well they will respond to treatment."

Who is the study for?

This trial is for adults over 18 with untreated esophageal cancer larger than 2 cm, who will receive chemo and radiation. They must be able to consent, not pregnant or breastfeeding, agree to use birth control, and have a body weight under 400 pounds without conditions preventing imaging.

What is being tested?

The trial is testing if a PET scan using the tracer ArabinoFuranosylGuanine (18F-F-AraG) can detect esophageal tumors and predict how well patients respond to chemoradiation treatment.

What are the potential side effects?

Potential side effects may include allergic reactions related to the PET scan contrast agent. The specifics of other side effects are not detailed but could relate to standard risks associated with PET/CT scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My esophageal cancer has not spread far from its original site.

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I have an untreated esophagus cancer larger than 2 cm and will get systemic therapy with radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I weigh over 400 pounds or have a condition that prevents me from undergoing certain scans.

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My kidney function is low, with an eGFR below 40.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and adverse events (AEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 18F-FAraG PETExperimental Treatment1 Intervention

Participants found to be eligible to take part in this study, participant will have a 18F-FAraG PET scan as described below. Before you start treatment, you will have standard-of-care imaging and then undergo the research 18F-FAraG PET scan. About 20 minutes before the injection of the 18F-FAraG imaging tracer, you will drink two 8-ounce bottles of water to help clear the imaging tracer from your kidneys.

0 / 5Eligibility criteria met