Non-small Cell Lung CancerPETRECNCT00686465
Positron Emission Tomography/Computed Tomography (PET/CT) for the Diagnosis of Recurrent Cancer: a Feasibility Study
A study testing PET/CT scan in people with Non-small Cell Lung Cancer and Breast Cancer, run by Ontario Clinical Oncology Group (OCOG) at 4 sites in Canada.
Trial summary
Sometimes, cancer comes back after it has been successfully treated-a situation called recurrent cancer. When recurrent cancer is suspected, the standard approach to diagnosis is to perform a combination of imaging tests, such as x-rays, ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer
- What is being tested?
- PET/CT scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 4 sitesCanada
- Study dates
- Mar 2009to Jul 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a previous history of non-small cell lung cancer, breast cancer, head and neck cancer (not thyroid cancer), ovarian cancer, esophageal cancer, or lymphoma (Hodgkin's or non-Hodgkin's) who have suspected recurrence on history and/or physical exam.
- Conventional imaging (e.g., X-ray, ultrasound, CT, MRI, bone scan) is non-diagnostic.
Who cannot join
- Age less than 18 years.
- Patient with established recurrence requiring staging of recurrent disease.
- Patients who, at the time of the initial evaluation, have already undergone PET/CT within 6 months prior to registration.
- Unable to lie supine for imaging with PET/CT.
- Pregnant or lactating female.
- Significant concurrent medical problems (e.g., uncontrolled diabetes, active cardiac disease, significant chronic obstructive pulmonary disease) making the patient unfit for further cancer therapy.
- Unable to give informed consent.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
London Health Sciences Centre
London, Ontario, N6A 4G5
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: Positron Emission Tomography/Computed Tomography (PET/CT) for the Diagnosis of Recurrent Cancer: a Feasibility Study. PET in Recurrent Cancer(PETREC)
Sometimes, cancer comes back after it has been successfully treated-a situation called recurrent cancer. When recurrent cancer is suspected, the standard approach to diagnosis is to perform a combination of imaging tests, such as x-rays, ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine scans. Sometimes, however, after performing these tests it still may not be clear whether or not the cancer has come back.
Some studies have shown that a diagnostic imaging test called Positron Emission Tomography/Computed Tomography (PET/CT) may be helpful in the diagnosis of recurrent lung, breast, head and neck, ovarian or esophageal cancer or lymphoma. However, it is not clear if PET/CT can offer better results than standard approaches to diagnosis.
This feasibility study is needed to determine how common it is for a diagnosis of recurrent cancer to be unclear even after standard diagnostic imaging tests have been completed. If the enrollment goal is reached (~60 patients enrolled in 18 months), a larger clinical trial is being planned to determine if PET/CT is helpful in making the diagnosis of recurrent cancer in situations where standard imaging tests have not been helpful. It is also expected that the results of this feasibility study will help to define exactly which patients should be enrolled in this larger clinical trial of PET/CT.
- Conditions
- Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer, Ovarian Cancer, Esophageal Cancer, Lymphoma
- Being tested
- PET/CT scan
- Keywords
- recurrent cancer, PET/CT, FDG, planned management, actual treatment
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Head and Neck Neoplasms, Ovarian Neoplasms, Esophageal Neoplasms, Lymphoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT scanOther
Patients will undergo whole body FDG-PET/CT imaging
| Study group | Role | What they receive |
|---|---|---|
| PET/CT scan | Other | PET/CT scan Receives: Other: PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients recruited in 18 months and the clinical characteristics of patients who are enrolled in the study
Measured: 21 months
Secondary outcomes (1)
The proportion of patients in whom the diagnosis of recurrent cancer is confirmed (as determined by either histology or clinical follow-up at the 3 month visit)
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2008 (estimated)
- Study startMar 2009
- Primary completionNov 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Responsible party
- Sponsor
- Investigators
- John J You, MD MSc FRCPC, Principal investigator, McMaster UniversityMark Levine, MD, Study director, Ontario Clinical Oncology Group (OCOG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00686465
- Sponsor's protocol ID
- OCOG-2007-PETREC
- Acronym
- PETREC
- Status last verified
- Feb 2013
- First submitted
- 22 May 2008
- Last updated
- 18 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomography/Computed Tomography (PET/CT) for the Diagnosis of Recurrent Cancer: a Feasibility Study. PET in Recurrent Cancer(PETREC)
- ClinicalTrials.gov ID
- NCT00686465
- Acronym / sponsor ID
- PETREC / OCOG-2007-PETREC
- Conditions
- Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer, Ovarian Cancer, Esophageal Cancer, Lymphoma
- Keywords
- recurrent cancer, PET/CT, FDG, planned management, actual treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Study start
- Mar 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 29 May 2008 (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.
Sometimes, cancer comes back after it has been successfully treated-a situation called recurrent cancer. When recurrent cancer is suspected, the standard approach to diagnosis is to perform a combination of imaging tests, such as x-rays, ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine scans. Sometimes, however, after performing these tests it still may not be clear whether or not the cancer has come back.
Some studies have shown that a diagnostic imaging test called Positron Emission Tomography/Computed Tomography (PET/CT) may be helpful in the diagnosis of recurrent lung, breast, head and neck, ovarian or esophageal cancer or lymphoma. However, it is not clear if PET/CT can offer better results than standard approaches to diagnosis.
This feasibility study is needed to determine how common it is for a diagnosis of recurrent cancer to be unclear even after standard diagnostic imaging tests have been completed. If the enrollment goal is reached (~60 patients enrolled in 18 months), a larger clinical trial is being planned to determine if PET/CT is helpful in making the diagnosis of recurrent cancer in situations where standard imaging tests have not been helpful. It is also expected that the results of this feasibility study will help to define exactly which patients should be enrolled in this larger clinical trial of PET/CT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/CT scan | Other | Other: PET/CT scanPET/CT scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a previous history of non-small cell lung cancer, breast cancer, head and neck cancer (not thyroid cancer), ovarian cancer, esophageal cancer, or lymphoma (Hodgkin's or non-Hodgkin's) who have suspected recurrence on history and/or physical exam.
- Conventional imaging (e.g., X-ray, ultrasound, CT, MRI, bone scan) is non-diagnostic.
Key exclusion criteria (7 listed)
- Age less than 18 years.
- Patient with established recurrence requiring staging of recurrent disease.
- Patients who, at the time of the initial evaluation, have already undergone PET/CT within 6 months prior to registration.
- Unable to lie supine for imaging with PET/CT.
- Pregnant or lactating female.
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/CT scanPatients will undergo whole body FDG-PET/CT imaging | Other | PET/CT scan |
Primary outcome
The number of patients recruited in 18 months and the clinical characteristics of patients who are enrolled in the study
Time frame: 21 months
1 secondary outcome
The proportion of patients in whom the diagnosis of recurrent cancer is confirmed (as determined by either histology or clinical follow-up at the 3 month visit)
Time frame: 21 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2013.
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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.
John J You, MD MSc FRCPC principal investigator
McMaster University
Mark Levine, MD study director
Ontario Clinical Oncology Group (OCOG)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/CT scan in people with Non-small Cell Lung Cancer and Breast Cancer, run by Ontario Clinical Oncology Group (OCOG) at 4 sites in Canada.
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 2 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: finished, as of the sponsor's last update on 18 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The number of patients recruited in 18 months and the clinical characteristics of patients who are enrolled in the study (time frame: 21 months). 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 18 Feb 2013.