Defining the Utility of PET/CT in the Follow-up of Patients With Solid Tumors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Dallas VA Medical Center
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
Brief 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).
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
PET/CT follow-up
PET/CT with history and physical exams at 3,9,18,36,60 months only
Intervention: PET/CT (Procedure)
conventional follow-up
NCCN recommendations
Intervention: NCCN recommendations for solid tumor post treatment (Procedure)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Improvement in patient/caregiver compliance in keeping their appointments and completing their tests(5 years)