PET Avidity in Cachexia-Inducing Lung and Gastrointestinal Tumors

Cachexia; Cancer Clinical Trial

Official title:

PET Avidity in Cachexia-Inducing Lung and Gastrointestinal Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03568019
• Other study ID #: STU 092013-001
• Status: Active, not recruiting
• Start date: November 26, 2013
• Est. completion date: February 15, 2026

Study information

• Verified date: May 2024
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10000
• Est. completion date: February 15, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cachexia
• Cachexia; Cancer
• Digestive System Neoplasms
• Gastrointestinal Neoplasms

Intervention

Other:
• Retrospective study
No subjects will be contacted or recruited. All data will be acquired retrospectively.

Locations

Country	Name	City	State
United States	UT Southwestern Medical Centre	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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