Actively Recruiting

Phase 1
Age: 18Years +
All Genders
ID06414902

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

Led by M.D. Anderson Cancer Center · Updated on 2026-05-19

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating if 18F-FAraG PET scans can detect tumors in people with esophageal cancer and predict how they respond to chemoradiation treatment. This phase 1 study aims to assess the imaging tracer's ability to identify cancer and forecast complete pathologic response, along with correlations with clinical features, tissue and blood biomarkers, and survival outcomes. Participants will receive a 18F-FAraG PET scan before starting their standard treatment. About 20 minutes before the scan, they will drink water to help clear the tracer from their kidneys. The tracer is given by intravenous injection. Standard imaging will also be done before treatment begins to compare with the research scan. During the study, researchers will monitor safety and adverse events for about one year. Participants will undergo the 18F-FAraG PET scan and standard imaging to evaluate tumor detection and treatment response. Blood and tissue samples may be collected to study biomarkers. The study tracks overall and disease-free survival as part of the long-term follow-up.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be 18 years of age or older
  • Participants with locally advanced esophageal cancer
  • Participants with untreated documented carcinoma of the esophagus larger than 2 cm who will receive systemic therapy concurrently with radiation as primary therapy
  • Ability to provide written informed consent
  • Female participants of childbearing potential must have a negative pregnancy test within 1 week prior to investigational PET/CT scan
  • Female participants of childbearing potential must agree to use adequate contraception prior to and during study participation
Not Eligible

You will not qualify if you...

  • Body weight 400 pounds or more or body habitus or disability preventing imaging protocol
  • Pregnant or lactating females
  • History of allergic reaction to intravenous contrast
  • Estimated glomerular filtration rate (eGFR) less than 40 within 1 month prior to receiving 18F-FAraG PET

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration of chemoradiation treatment

Participants receive the 18F-FAraG PET scan and standard-of-care chemoradiation treatment to evaluate tumor response.

1 baseline 18F-FAraG PET scan and standard-of-care imaging before treatment

Follow-up

Duration - Up to 1 year after treatment completion

Participants are monitored for safety, adverse events, and treatment response up to approximately 1 year after treatment completion.

Periodic visits for safety and response assessments

Trial Site Locations

Total: 1 location

1

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

S

Steven Lin, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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