Positron Emission Tomography/Computed Tomography (PET/CT) for the Diagnosis of Recurrent Cancer: a Feasibility Study (PETREC)
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Purpose
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 | Intervention |
|---|---|
|
Non-small Cell Lung Cancer Breast Cancer Head and Neck Cancer Ovarian Cancer Esophageal Cancer Lymphoma |
Other: PET/CT scan |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: 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) |
- The number of patients recruited in 18 months and the clinical characteristics of patients who are enrolled in the study [ Time Frame: 21 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 101 |
| Study Start Date: | March 2009 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
PET/CT scan
PET/CT scan
|
Other: PET/CT scan
Patients will undergo whole body FDG-PET/CT imaging
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| 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 | |
| Principal Investigator: | John J You, MD MSc FRCPC | McMaster University |
| Study Director: | Mark Levine, MD | Ontario Clinical Oncology Group (OCOG) |
More Information
No publications provided
| Responsible Party: | Ontario Clinical Oncology Group (OCOG) |
| ClinicalTrials.gov Identifier: | NCT00686465 History of Changes |
| Other Study ID Numbers: | OCOG-2007-PETREC |
| Study First Received: | May 22, 2008 |
| Last Updated: | February 15, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Ontario Clinical Oncology Group (OCOG):
|
recurrent cancer PET/CT FDG planned management actual treatment |
Additional relevant MeSH terms:
|
Breast Neoplasms Carcinoma, Non-Small-Cell Lung Esophageal Diseases Esophageal Neoplasms Head and Neck Neoplasms Lung Neoplasms Lymphoma Ovarian Neoplasms Recurrence Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Endocrine Gland Neoplasms Ovarian Diseases |
ClinicalTrials.gov processed this record on May 16, 2013