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

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Esophageal Carcinoma

Treatments: Other: Non-Interventional Study

Study type: Observational

Funder types: Other

Identifiers

NCT06549413

NCI-2023-04988 (Registry Identifier)

2022-0989 (Other Identifier)

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES:

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

Observational

Description:

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.

Treatment:

Other: Non-Interventional Study