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

NCT06549413 | Recruiting FDA Drug

• 2 other identifiers: 2022-0989NCI-2023-04988
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events (AEs)

  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.

Study Arms (1)

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

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• \* ≥ 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

You may not qualify if:

• \* 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Steven H Lin, MD, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven H Lin, MD, PHD

CONTACT

713-563-2300; shlin@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 12, 2024
• Study Start: August 23, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)