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

May 12, 2026 updated by: M.D. Anderson Cancer Center
This study is being done to learn how 18F-FSPG PET/CT scan results may be related to the response to chemotherapy and radiation in patients with esophageal cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. Evaluate the ability of 18F-FSPG PET imaging to detect tumors in patients with esophageal cancer.

Study Type

Observational

Enrollment (Estimated)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with locally advanced esophageal cancer being seen at the Thoracic Radiation Oncology Section at the University of Texas MD Anderson Cancer Center (MDACC).

Description

Inclusion Criteria:

  • * ≥ 18 years of age

    • Patients with locally advanced esophageal cancer
    • Patients with untreated documented carcinoma of the esophagus that is > 2 cm who are going to receive systemic therapy concurrently with radiation as primary therapy
    • Ability to provide written informed consent in accordance with institutional policies
    • Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 1 week of the proposed investigational PET/CT scan(s) prior to injection of the investigational radiopharmaceutical

Exclusion Criteria:

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

    • Pregnant or lactating females
    • Have an allergy to intravenous contrast
    • eGFR < 30

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational
Patients receive 18F-FSPG IV and undergo a PET/CT scan. During week 3 of standard of care radiation therapy, patients receive 18F-FSPG and undergo a second PET/CT scan on study.
Other: Non-Interventional Study
Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and adverse events (AEs)
Time Frame: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Through study completion; an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Steven H Lin, MD, PHD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

August 9, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-0989 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2023-04988 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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