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Active, Not Recruiting

NCT Number: NCT06549413

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Esophageal Carcinoma Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

PRIMARY OBJECTIVES:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2024
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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