PET Avidity in Cachexia-Inducing Lung and Gastrointestinal Tumors

Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03568019
Collaborator
(none)
10,000
1
146.7
68.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
10000 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
PET Avidity in Cachexia-Inducing Lung and Gastrointestinal Tumors
Actual Study Start Date :
Nov 26, 2013
Anticipated Primary Completion Date :
May 26, 2024
Anticipated Study Completion Date :
Feb 15, 2026

Outcome Measures

Primary Outcome Measures

  1. A retrospective review to determine if PET can be used to identify cachexia-inducing lung and gastrointestinal tumors [10 years]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 UT Southwestern Medical Centre Dallas Texas United States 75390

Sponsors and Collaborators

  • University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Puneeth Iyengar, MD, UTSW Radiation Oncology
  • Principal Investigator: Orhan Oz, MS, UTSW Radiation Oncology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Puneeth Iyengar, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT03568019
Other Study ID Numbers:
  • STU 092013-001
First Posted:
Jun 26, 2018
Last Update Posted:
May 4, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 4, 2022