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

Recruiting

• Conditions: Esophageal Carcinoma

• Registration Number: NCT06549413
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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.

Detailed Description

PRIMARY OBJECTIVES:

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

Study Timeline

• Study Start: 2023-08-23
• Study First Submitted: 2024-08-08
• Study First Submitted QC: 2024-08-09
• Study First Posted: 2024-08-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Primary Completion: 2025-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and adverse events (AEs)	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

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States