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

• Conditions: Colo-rectal Cancer; Recurrence
• Interventions: Diagnostic Test: F-18 FDG-PET/CT

• Registration Number: NCT03572595
• Lead Sponsor: Assiut University

Brief Summary

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.

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 Timeline

• Status Verified: 2018-06
• Study First Submitted: 2018-06-09
• Study First Submitted QC: 2018-06-19
• Last Update Submitted: 2018-06-19
• Study First Posted: 2018-06-28
• Last Update Posted: 2018-06-28
• Study Start: 2018-07-01
• Primary Completion: 2019-07-01
• Study Completion: 2020-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Recurrent	F-18 FDG-PET/CT	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 .
Staging	F-18 FDG-PET/CT	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.

Primary Outcome Measures

Name	Time	Method
How many patients will be upstaged or downstaged by using pre-operative F-18 FDG_PET/CT in patients with colorectal cancer.	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 .

Secondary Outcome Measures

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