Defining the Utility of Positron Emission Tomography/Computed Tomography (PET/CT)in the Follow-up of Patients With Solid Tumors - Full Text View

Sponsored by:	Dallas VA Medical Center
Information provided by:	Dallas VA Medical Center
ClinicalTrials.gov Identifier:	NCT00954148

Purpose

This is a comparison, at this VA Hospital,of routine multi-visit and multi-testing for solid tumor recurrence in four tumor groups to a limited scheduled 5 visit history/physical with PET/CT only, over a five year period. The purpose is to show through utilization of the single most sensitive and specific test currently available-PET/CT-that survival for patients in follow-up can be improved.(Plus lowering medical costs and increasing patient confidence and compliance with follow-up appointments).

Condition	Intervention
Cancer Recurrence Solid Tumors	Procedure: PET/CT Procedure: NCCN recommendations for solid tumor post treatment

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Defining the Utility of PET/CT in the Follow-up of Patients With Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Dallas VA Medical Center:

Primary Outcome Measures:

ThatPET/CT will be superior (15% improvement) to conventional methods of follow-up in terms of 5 year survival, cost and time to identification of new disease [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Improvement in patient/caregiver compliance in keeping their appointments and completing their tests [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	September 2009
Estimated Study Completion Date:	October 2014
Estimated Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PET/CT follow-up: Active Comparator PET/CT with history and physical exams at 3,9,18,36,60 months only	Procedure: PET/CT 5 visits with PET/CT as only testing
conventional follow-up NCCN recommendations	Procedure: NCCN recommendations for solid tumor post treatment 12-14 visits with exams, blood tests, CTs and PET/CT

Detailed Description:

Routine visits would include COLON:14 visits with cea and 6 CTs over a 5 year period plus PET/CT at last visit RECTAL: 14 visits with cea and 6 CTs and 4 procto exams over 5 year period plus PET/CT at last visit HEAD/NECK: 14 visits with 4 CTs and PET/CT at last visit LUNG:12 visits plus 4 CTs and PET/CT at last visit

Limited follow-up ALL GROUPS: a history and physical plus PET/CT at 3 month, 9 month, 18 month, 36 month and 60 month only

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Completed primary therapy such that no disease is evident at the time of enrollment in the study

Exclusion Criteria:

Patients unable to consent
Without diagnosis of colorectal cancer
Non-small cell lung cancer or squamous cell cancer of the head and neck
Unwilling or unable to participate in the assigned follow-up program
Having a serum glucose at time of PET/CT greater than 180mg/dl
Stage IV disease or with evidence of disease recurrence post treatment
Who are not a candidate for further treatment should a recurrence of disease be identified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954148

Locations

United States, Texas
VA North Texas Health Care System
Dallas, Texas, United States, 75216

Sponsors and Collaborators

Dallas VA Medical Center

Investigators

Study Chair:

James LePage, PH.D

ACOS for Research VA North TX Health Care System

More Information

No publications provided

Responsible Party:	VANTXHCS Dallas, TX ( Thomas Anthony, MD Chief of Surgery )
Study ID Numbers:	09-017
Study First Received:	August 5, 2009
Last Updated:	September 1, 2009
ClinicalTrials.gov Identifier:	NCT00954148 History of Changes
Health Authority:	United States: Federal Government; United States: Institutional Review Board

Keywords provided by Dallas VA Medical Center:

cancer
colorectal
head/neck
lung
PET/CT

Study placed in the following topic categories:

Recurrence

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Recurrence

ClinicalTrials.gov processed this record on September 11, 2009