PET Avidity in Cachexia-Inducing Lung and Gastrointestinal Tumors

PET has an established role in the initial staging of patients with newly diagnosed lung and gastrointestinal tumors.PET avidity is described with both maximum and mean standardized uptake values.Malignant cells have increased activity on PET, defined as the standardized uptake value (SUV), with increased uptake of FDG in tumor due to elevated levels of GLUT receptors, elevated intracellular levels of hexokinase and increased rates of glycolysis. However, there is a subset of patients with lung and gastrointestinal tumors that are not PET avid.These patients may present with clinically and systemically aggressive disease with a declining performance status and/or weight loss.

Study Overview

• Status: Active, not recruiting
• Conditions: Cachexia; Cancer
• Intervention / Treatment: Other: Retrospective study

Detailed Description

This study will be a retrospective review of patients in the tumor registry with lung and gastrointestinal tumors, not limited to but including small and non-small cell lung cancers, stomach cancer, small intestinal cancer, colon cancer, rectal cancer, liver and intrahepatic bile duct cancers, gallbladder and extrahepatic bile duct cancers, and pancreatic cancer.

There will be a maximum of 10,000 charts/records that will be reviewed to compile the data. Data to be collected will include patients' name, medical record number, date of birth, race, ethnicity, gender, medical history, medications, vital and performance status, vital signs including weight and body mass index, date of cancer diagnosis, clinical and pathologic stage, pathology, treatment course, prior treatment, location of primary lesion, and smoking history. CT and PET findings to be reviewed include the number of involved lymph nodes, size of primary tumor, average/maximum PET avidity in both the primary tumor and involved lymph nodes.

• Study Type: Observational
• Enrollment (Actual): 10000

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

No subjects will be contacted or recruited. All data will be acquired retrospectively. The medical charts are the subjects. The data from these charts will be entered into a password protected excel spreadsheet.The charts will be identified by name, medical record number, and date of birth. At the time of study, many of the patients will have expired but some will be alive and in the regional North Texas area. Thus, given the fact the majority of patients will have expired at the time of this study and the minimal risk nature of this retrospective chart review, we could not reasonably conduct this research with a full waiver of consent. The research involves no more than minimal risk to the subjects; the waiver or alteration will not adversely affect the rights and welfare of the subjects; the research could not practicably be carried out without the waiver or alteration.

Description

Inclusion Criteria:

Patients with histologically proven lung and gastrointestinal cancers, stages I-IV with PET and/or CT within 6 weeks of diagnosis.

Exclusion Criteria:

There will be no absolute exclusion criteria as long as the inclusion criteria have been met.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A retrospective review to determine if PET can be used to identify cachexia-inducing lung and gastrointestinal tumors	The goal of this assessment is to identify patients with lung and gastrointestinal tumors and collect the data on tumor stage location, histology, PET avidity, and weight loss/performance status so that it will be possible to correlate SUV values associated with cachexia by using CTCAE version 4.0 to collect and log AE and SAE related to cachexia.	10 years

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Puneeth Iyengar, MD, UTSW Radiation Oncology; Principal Investigator: Orhan Oz, MS, UTSW Radiation Oncology

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2013
• Primary Completion (Anticipated): May 26, 2024
• Study Completion (Anticipated): February 15, 2026

Study Registration Dates

• First Submitted: May 14, 2018
• First Submitted That Met QC Criteria: June 21, 2018
• First Posted (Actual): June 26, 2018

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Nutrition Disorders; Body Weight; Body Weight Changes; Emaciation; Weight Loss; Gastrointestinal Neoplasms; Digestive System Neoplasms; Wasting Syndrome; Cachexia
• Other Study ID Numbers: STU 092013-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No