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Positron Emission Tomography/Computed Tomography (PET/CT) for the Diagnosis of Recurrent Cancer: a Feasibility Study (PETREC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00686465
Recruitment Status : Completed
First Posted : May 29, 2008
Last Update Posted : February 18, 2013
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)

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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Breast Cancer Head and Neck Cancer Ovarian Cancer Esophageal Cancer Lymphoma Other: PET/CT scan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Positron Emission Tomography/Computed Tomography (PET/CT) for the Diagnosis of Recurrent Cancer: a Feasibility Study. PET in Recurrent Cancer(PETREC)
Study Start Date : March 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : July 2012

Arm Intervention/treatment
PET/CT scan
PET/CT scan
Other: PET/CT scan
Patients will undergo whole body FDG-PET/CT imaging

Primary Outcome Measures :
  1. 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 Measures :
  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) [ Time Frame: 21 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00686465

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Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada, P7B 6V4
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Ontario Ministry of Health and Long Term Care
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Principal Investigator: John J You, MD MSc FRCPC McMaster University
Study Director: Mark Levine, MD Ontario Clinical Oncology Group (OCOG)

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Responsible Party: Ontario Clinical Oncology Group (OCOG) Identifier: NCT00686465     History of Changes
Other Study ID Numbers: OCOG-2007-PETREC
First Posted: May 29, 2008    Key Record Dates
Last Update Posted: February 18, 2013
Last Verified: February 2013

Keywords provided by Ontario Clinical Oncology Group (OCOG):
recurrent cancer
planned management
actual treatment

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Head and Neck Neoplasms
Esophageal Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Disease Attributes
Pathologic Processes