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Defining the Utility of PET/CT in the Follow-up of Patients With Solid Tumors


N/A
18 Years
90 Years
Not Enrolling
Both
Cancer Recurrence, Solid Tumors

Thank you

Trial Information

Defining the Utility of PET/CT in the Follow-up of Patients With Solid Tumors


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

James LePage, PH.D

Investigator Role:

Study Chair

Investigator Affiliation:

ACOS for Research VA North TX Health Care System

Authority:

United States: Federal Government

Study ID:

09-017

NCT ID:

NCT00954148

Start Date:

September 2009

Completion Date:

June 2010

Related Keywords:

  • Cancer Recurrence
  • Solid Tumors
  • cancer
  • colorectal
  • head/neck
  • lung
  • PET/CT
  • Recurrence
  • Neoplasms

Name

Location

VA North Texas Health Care SystemDallas, Texas  75216