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

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.

Study Overview

• Status: Completed
• Conditions: Lymphoma; Breast Cancer; Head and Neck Cancer; Esophageal Cancer; Ovarian Cancer; Non-small Cell Lung Cancer
• Intervention / Treatment: Other: PET/CT scan

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Juravinski Cancer Centre
    • London, Ontario, Canada, N6A 4G5
      • London Health Sciences Centre
    • Thunder Bay, Ontario, Canada, P7B 6V4
      • Thunder Bay Regional Health Sciences Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: PET/CT scan	Other: PET/CT scan; Patients will undergo whole body FDG-PET/CT imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of patients recruited in 18 months and the clinical characteristics of patients who are enrolled in the study	21 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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)	21 months

Collaborators and Investigators

• Sponsor: Ontario Clinical Oncology Group (OCOG)
• Collaborators: Ontario Ministry of Health and Long Term Care
• Investigators: Principal Investigator: John J You, MD MSc FRCPC, McMaster University

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: May 22, 2008
• First Submitted That Met QC Criteria: May 23, 2008
• First Posted (Estimate): May 29, 2008

Study Record Updates

• Last Update Posted (Estimate): February 18, 2013
• Last Update Submitted That Met QC Criteria: February 15, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: PET/CT; FDG; recurrent cancer; planned management; actual treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: OCOG-2007-PETREC