F-18 FDG- PETCT in Staging and Recurrent Colorectal Cancer

June 19, 2018 updated by: Shymaa Mohamed, Assiut University

Diagnostic Accuracy of Positron Emission Tomography/ Computed Tomography With 18F-fluoro-2-deoxyglucose (18F- FDG PET/CT) in Patients With Colorectal Cancer

Colorectal cancer (CRC) is the fourth most frequently diagnosed cancer and the second leading cause of cancer death in the United States.

The overall relative 5-year survival is about 50%-60% but is highly dependent on disease stage at the time of diagnosis ranging from approximately 80% to only 3%.

Curative treatment comprises resection of the primary tumour combined with adjuvant chemotherapy in selected patients. In recent years there has been an increasing role for curative intended surgical or ablative intervention in limited metastatic disease, i.e., solitary or few metastases to the liver and/or the lungs. Accurate preoperative staging is of paramount importance for directing the most appropriate therapeutic options, for indicating prognosis and outcome, and to avoid futile operations.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The use of imaging in the staging and restaging of colorectal cancers has been evolving and improving in the last two decades. Magnetic resonance imaging (MRI) is an accepted modality for staging of rectal cancer, allowing an accurate identification of transmural invasion of the mesorectal fat and mesorectal fascia involvement. Computed tomography (CT) significantly lacks resolution of soft tissue contrast so that its utility in T staging of rectal cancer is limited. Due to the higher sensitivity and specificity compared with CT,Positron Emission Tomography/ Computed Tomography with 18F-fluoro-2-deoxyglucose (FDG PET/CT) is recommended for use in a metastatic patients.

Pelvic MRI and 18F-FDG PET/CT are useful for staging and therapeutic management. Pelvic MRI allows for accurate definition of the distance to mesorectal fascia which is a predictor of the local recurrence rate, as well as for definition of the regional nodal status. 18F-FDG PET/CT also helps in evaluating the nodal status and is especially performed for the detection of distant metastases. MRI and 18F-FDG PET/CT are thus 2 complementary modalities for the initial staging of advanced rectal cancer.

Neoadjuvant therapies are performed for stage II and stage III rectal cancer. It has been shown that neoadjuvant therapy decreases local recurrence and increases survival. Therefore, correct preoperative staging has a critical role in determining whether patients should undergo neoadjuvant therapy.

The literature on the clinical use of FDG-PET/CT in colorectal cancer staging is fairly limited, but recent works have demonstrated some promise for optimizing the accuracy of initial staging by clarifying equivocal findings on conventional imaging in preoperative staging, and evaluating apparently limited metastatic disease before intervention .

It was reported that the use of FDG-PET/CT in this study changed the planned treatment strategy in a total of 30% of the patients. A change from palliative to curative or vice versa was seen in almost 10% of the patients.

PET/CT provides high accuracy for the detection and staging of liver lesions in CRC patients, PET led to a change in patient management in an average of 24 % of patients, including both exclusion from curative surgery and modification of the surgical approach.

Risk of local recurrence is substantial and correlates to the extension and grade of the tumor and to the nodal status at initial presentation. The guidelines also highlight the usefulness of PET/CT for restaging in the setting of a serially elevated carcinoembryonic antigen level (CEA), negative results on conventional imaging, and potentially resectable metachronous metastases documented by CT, MRI, or biopsy.It was reported that a high sensitivity and specificity of 18F-FDG PET/CT in detecting recurrent CRC, largely regardless of CEA levels, as well as they concluded that 18F-FDG PET/CT have high diagnostic value and can be used as the first choice in the detection of recurrent CRC in patients with unexplained rising CEA, even in patients with a recent normal routine CT.

Study Type

Observational

Enrollment (Anticipated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients daignosed with colorectal cancer , presented for pre-operative staging, so after doing the standard routine conevntional imaging , they will be sceduled to be imaged with F_18 FDG_PET/CT , hpothezied that the latter has potential promosing role in staging of those patients and lead to change of mangenent.

As well, patients with treated colorectal cancer , under follow up, suspecting recurrence , will be sceduled to be iamged with F-18 FDG-PET/CT for determing is role in those patients.

Description

Inclusion Criteria:

  • Patients with pathologically proven colorectal cancer presented for pre-operative staging or restaging.
  • Patients with treated colorectal cancer , suspecting recurrence .

Exclusion Criteria:

  • Pregnancy.
  • Patients with double primary.
  • Expected life less than 3 months.
  • Uncontrolled diabetes or elevated blood sugar more than 200 mg/dl.
  • Severe medical condition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Staging
Patients with pathologically proven colorectal cancer presented for pre-operative staging, underwent standard routine conventional radiological imaging i.e MRI , then will be subjected to be imaged by F-18 FDG-PET/CT from skullbase to midthigh, then interpretating the results of the hybrid PET/CT by two nuclear physicians then comparing with other conventional images.
Diagnostic test: F-18 FDG-PET/CT
imaging using Positron Emission Tomography/ Computed Tomography with 18F-fluoro-2-deoxyglucose (18F- FDG PET/CT) in Patients with colorectal cancer either for staging or suspecting recurrence
Recurrent

Patients with treated colorectal cancer, suspecting of recurrence , will be subjected to be imaged by F-18 FDG-PET/CT from skull base to midthigh, interpretating the results of the hybrid PET/CT by two nuclear physicians.

Then refer back to the treating physicians , another biopsy will be taken from the suspected recurrence and then results will be compared with hybrid PET/CT images.

comparing the results with histopathology .
Diagnostic test: F-18 FDG-PET/CT
imaging using Positron Emission Tomography/ Computed Tomography with 18F-fluoro-2-deoxyglucose (18F- FDG PET/CT) in Patients with colorectal cancer either for staging or suspecting recurrence

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
How many patients will be upstaged or downstaged by using pre-operative F-18 FDG_PET/CT in patients with colorectal cancer.
Time Frame: 2 weeks after the patients have been diagnosed and presented for treatment
role of F-18 FDG_PET/CT in staging of colorectal cancer patient .
2 weeks after the patients have been diagnosed and presented for treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients will be diagnosed recurrent colorectal cancer by using F-18 FDG_PET/CT in case of negative other conventional imaging.
Time Frame: one week
which is better F-18 FDG_PET/CT or other conventional imaging
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Mohammed Mekkay, PHD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 1, 2018

Primary Completion (ANTICIPATED)

July 1, 2019

Study Completion (ANTICIPATED)

February 1, 2020

Study Registration Dates

First Submitted

June 9, 2018

First Submitted That Met QC Criteria

June 19, 2018

First Posted (ACTUAL)

June 28, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 19, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPETCRC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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