NCT06549413
Recruiting
Not Applicable
18F-FSPG PET/CT as a Non-Invasive Imaging Biomarker for Treatment Response to Chemoradiation in Esophageal Cancer
ConditionsEsophageal Carcinoma
InterventionsNon-Interventional Study
Overview
- Phase
- Not Applicable
- Intervention
- Non-Interventional Study
- Conditions
- Esophageal Carcinoma
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Safety and adverse events (AEs)
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: Non-Interventional Study
Outcomes
Primary Outcomes
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
Study Sites (1)
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