FDG-Positron Emission Tomography (PET)/CT In the Evaluation of Persistent Febrile Neutropenia in Cancer Patients

NCT00707213 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: HCI22418R21CA128228-01
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Patients must be currently treated at the Huntsman Cancer Institute or Intermountain Primary Children's Medical Center to be eligible for this study. Although there have been many advances in the assessment and treatment of infections responsible for febrile neutropenia in cancer patients, it still remains a common complication of cancer therapy and accounts for the majority of chemotherapy-associated deaths. This National Cancer Institute (NCI) funded proposal using the R-21 Quick-Trials Exploratory Grant mechanism is to conduct an exploratory/pilot project in a group of patients with persistent febrile neutropenia to provide critical information that will support the concept, and aid in the design, of a larger multi-center clinical trial. The ultimate goal of our interdisciplinary team of oncologists, infectious diseases experts, imagers, and biostatisticians is to conduct a prospective, multi-center trial to establish the utility and cost-effectiveness of PET/CT using the widely available glucose analogue \[18F\]fluoro-2-deoxy-D-glucose (FDG) in identifying sites of infection in cancer patients with persistent febrile neutropenia without an obvious identifiable source thus improving targeted therapy.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• The primary goal of this study is to perform FDG-PET/CT scans in approximately 100 cancer patients (both adults and children) with persistent febrile neutropenia where the source of infection has not been identified.

  December 2011

Study Arms (1)

All Participants

EXPERIMENTAL

All Participants will be assessed by FDG-PET to identify possible sites of infection

Drug: [18F]fluoro-2-deoxy-D-glucose (FDG)

Interventions

[18F]fluoro-2-deoxy-D-glucose (FDG) DRUG

FDG-PET/CT scan-The scans that will be done with a radioactive sugar (\[18F\]fluoro-2-deoxy-D-glucose) and positron emission tomography (FDG-PET/CT). These scans will help to identify areas of possible infection.

Also known as: FDG, [18F]FDG, FDG-PET/CT

All Participants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Adult patients:
• Of note, patients from the bone marrow transplant unit will be eligible to participate in this pilot study,. Many of these patients are placed on prophylactic antifungal agents at the time of presentation of neutropenia and fever. This may cause a drug-induced fever in a certain percentage of recipients. For this reason, the clinical picture is clouded however the patients may still have an occult infection. Bone marrow transplant patients will be included in the study as this is an exploratory study and the information gained from assessing the ability of FDG-PET/CT to localize sites of infection in neutropenic, febrile bone marrow transplant patients will be valuable.

Sponsors & Collaborators

• University of Utah: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Fluorodeoxyglucose F18

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• John M Hoffman, MD

  Huntsman Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2008
• First Posted: June 30, 2008
• Study Start: August 21, 2007
• Primary Completion: August 11, 2010
• Study Completion: August 11, 2010
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

US (1)