Cancer RecurrenceNCT00954148
Defining the Utility of PET/CT in the Follow-up of Patients With Solid Tumors
A study testing PET/CT and NCCN recommendations for solid tumor post treatment in people with Cancer Recurrence and Solid Tumors, run by Dallas VA Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cancer Recurrence, Solid Tumors
- What is being tested?
- PET/CT and NCCN recommendations for solid tumor post treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completed primary therapy such that no disease is evident at the time of enrollment in the study
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
VA North Texas Health Care System
Dallas, Texas, 75216
About this study
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).
Read the 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
- Conditions
- Cancer Recurrence, Solid Tumors
- Being tested
- PET/CT, NCCN recommendations for solid tumor post treatment
- Keywords
- cancer, colorectal, head/neck, lung, PET/CT
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CTProcedure or surgery
5 visits with PET/CT as only testing
NCCN recommendations for solid tumor post treatmentProcedure or surgery
12-14 visits with exams, blood tests, CTs and PET/CT
| Study group | Role | What they receive |
|---|---|---|
| PET/CT follow-up | Active comparator | PET/CT with history and physical exams at 3,9,18,36,60 months only Receives: Procedure: PET/CT |
| conventional follow-up | Other | NCCN recommendations Receives: Procedure: NCCN recommendations for solid tumor post treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (1)
Improvement in patient/caregiver compliance in keeping their appointments and completing their tests
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2010
- Study completionJun 2010
Why it stopped: 1st years Enrollment #s showed study was not going to meet criteria randomization.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer RecurrenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dallas VA Medical Center
- Sponsor type
- US federal agency
- Investigators
- James LePage, PH.D, Study chair, ACOS for Research VA North TX Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954148
- Sponsor's protocol ID
- 09-017
- Status last verified
- May 2010
- First submitted
- 5 Aug 2009
- Last updated
- 30 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Utility of PET/CT in the Follow-up of Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT00954148
- Acronym / sponsor ID
- 09-017
- Conditions
- Cancer Recurrence, Solid Tumors
- Keywords
- cancer, colorectal, head/neck, lung, PET/CT
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 1st years Enrollment #s showed study was not going to meet criteria randomization.
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Dallas VA Medical CenterUS federal agency
- Study start
- Sep 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 7 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PET/CT follow-up | Active comparator | Procedure: PET/CTPET/CT with history and physical exams at 3,9,18,36,60 months only |
| conventional follow-up | Other | Procedure: NCCN recommendations for solid tumor post treatmentNCCN recommendations |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Completed primary therapy such that no disease is evident at the time of enrollment in the study
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/CT5 visits with PET/CT as only testing | Procedure or surgery | PET/CT follow-up |
| NCCN recommendations for solid tumor post treatment12-14 visits with exams, blood tests, CTs and PET/CT | Procedure or surgery | conventional follow-up |
Primary outcome
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
1 secondary outcome
Improvement in patient/caregiver compliance in keeping their appointments and completing their tests
Time frame: 5 years
Results and safety
The study was stopped early (reason given: 1st years Enrollment #s showed study was not going to meet criteria randomization.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James LePage, PH.D study chair
ACOS for Research VA North TX Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/CT and NCCN recommendations for solid tumor post treatment in people with Cancer Recurrence and Solid Tumors, run by Dallas VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 1st years Enrollment #s showed study was not going to meet criteria randomization.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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 (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2010; AzTrials last refreshed its copy on 8 Nov 2026.