18F-FSPG PET/CT as a Non-Invasive Imaging Biomarker for Treatment Response to Chemoradiation in Esophageal Cancer
Recruiting
- Conditions
- Esophageal Carcinoma
- Interventions
- Other: Non-Interventional Study
- 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.
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
- Arm && Interventions
Group Intervention Description Observational Non-Interventional Study 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.
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States