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Trial Title:
18F-FSPG PET/CT as a Non-Invasive Imaging Biomarker for Treatment Response to Chemoradiation in Esophageal Cancer
NCT ID:
NCT06549413
Condition:
Esophageal Carcinoma
Conditions: Official terms:
Esophageal Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Non-Interventional Study
Description:
Non-interventional study
Arm group label:
Observational
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.
Criteria for eligibility:
Study pop:
Patients with locally advanced esophageal cancer being seen at the Thoracic Radiation
Oncology Section at the University of Texas MD Anderson Cancer Center (MDACC).
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Steven H. Lin, MD, PHD
Phone:
713-563-2300
Email:
shlin@mdanderson.org
Investigator:
Last name:
Steven H. Lin
Email:
Principal Investigator
Start date:
August 23, 2023
Completion date:
December 31, 2027
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06549413
http://www.mdanderson.org
