Positron Emission Tomography/Computed Tomography (PET/CT) for the Diagnosis of Recurrent Cancer: a Feasibility Study (PETREC)
Primary Purpose
Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PET/CT scan
Sponsored by

About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring recurrent cancer, PET/CT, FDG, planned management, actual treatment
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Juravinski Cancer Centre
- London Health Sciences Centre
- Thunder Bay Regional Health Sciences Centre
- Princess Margaret Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
PET/CT scan
Arm Description
PET/CT scan
Outcomes
Primary Outcome Measures
The number of patients recruited in 18 months and the clinical characteristics of patients who are enrolled in the study
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT00686465
First Posted
May 22, 2008
Last Updated
February 15, 2013
Sponsor
Ontario Clinical Oncology Group (OCOG)
Collaborators
Ontario Ministry of Health and Long Term Care
1. Study Identification
Unique Protocol Identification Number
NCT00686465
Brief Title
Positron Emission Tomography/Computed Tomography (PET/CT) for the Diagnosis of Recurrent Cancer: a Feasibility Study
Acronym
PETREC
Official Title
Positron Emission Tomography/Computed Tomography (PET/CT) for the Diagnosis of Recurrent Cancer: a Feasibility Study. PET in Recurrent Cancer(PETREC)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ontario Clinical Oncology Group (OCOG)
Collaborators
Ontario Ministry of Health and Long Term Care
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PET/CT scan
Arm Type
Other
Arm Description
PET/CT scan
Intervention Type
Other
Intervention Name(s)
PET/CT scan
Intervention Description
Patients will undergo whole body FDG-PET/CT imaging
Primary Outcome Measure Information:
Title
The number of patients recruited in 18 months and the clinical characteristics of patients who are enrolled in the study
Time Frame
21 months
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John J You, MD MSc FRCPC
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Levine, MD
Organizational Affiliation
Ontario Clinical Oncology Group (OCOG)
Official's Role
Study Director
Facility Information:
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Thunder Bay Regional Health Sciences Centre
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B 6V4
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Positron Emission Tomography/Computed Tomography (PET/CT) for the Diagnosis of Recurrent Cancer: a Feasibility Study
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