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

D

Dallas VA Medical Center

Status

Terminated

Conditions

Cancer Recurrence
Solid Tumors

Treatments

Procedure: PET/CT
Procedure: NCCN recommendations for solid tumor post treatment

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

Details and patient eligibility

About

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).

Full 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

Enrollment

53 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

53 participants in 2 patient groups

PET/CT follow-up
Active Comparator group
Description:
PET/CT with history and physical exams at 3,9,18,36,60 months only
Treatment:
Procedure: PET/CT
conventional follow-up
Other group
Description:
NCCN recommendations
Treatment:
Procedure: NCCN recommendations for solid tumor post treatment

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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