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

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00954148
• Other study ID #: 09-017
• Status: Terminated
• Phase: N/A
• First received: August 5, 2009
• Last updated: June 29, 2010
• Start date: September 2009
• Est. completion date: June 2010

Study information

• Verified date: May 2010
• Source: Dallas VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 53
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cancer Recurrence
• Recurrence
• Solid Tumors

Intervention

Procedure:
• PET/CT
5 visits with PET/CT as only testing
• NCCN recommendations for solid tumor post treatment
12-14 visits with exams, blood tests, CTs and PET/CT

Locations

Country	Name	City	State
United States	VA North Texas Health Care System	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Dallas VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		5 years	No
Secondary	Improvement in patient/caregiver compliance in keeping their appointments and completing their tests		5 years	No