Defining the Utility of PET/CT in the Follow-up of Patien... | NCT00954148

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

NCT00954148

Sponsor

Dallas VA Medical Center

Status

Terminated

Last Update Posted

Jun 30, 2010Estimated

Enrollment

53Actual

Phase

Not Applicable

Conditions

Cancer Recurrence
Solid Tumors

Interventions

PET/CT
NCCN recommendations for solid tumor post treatment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

1st years Enrollment #s showed study was not going to meet criteria randomization.

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

May 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Aug 5, 2009

First Submission Date that Met QC Criteria

Aug 6, 2009

First Posted Date

Aug 7, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 29, 2010

Last Update Posted Date

Jun 30, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PET/CT	Procedure	5 visits with PET/CT as only testing	PET/CT follow-up

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
Improvement in patient/caregiver compliance in keeping their appointments and completing their tests		5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James LePage, PH.D	ACOS for Research VA North TX Health Care System	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA North Texas Health Care System		Dallas	Texas	75216	United States

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided