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Positron Emission Tomography - Computed Tomography (PET-CT) Cetuximab Project

NCT ID: NCT00828620

Last Updated: 2012-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-06-30

Brief Summary

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Molecular imaging with positron emission tomography (PET) using \[18F\] fluorodeoxyglucose (FDG) has been suggested as an early, sensitive marker of tumour response to anticancer drugs by monitoring the changes in glucose metabolism in tumours. Recently, FDG-PET has shown to be highly sensitive in detecting early response in other tumours. In this study, the investigators will prospectively investigate the role of early FDG-PET (at day 7 and week 6) in outcome prediction.

Detailed Description

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Conditions

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Metastatic Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PET-CT

Patients with Unresectable stage IV colorectal cancer; eligible for 3rd line Irinotecan and Cetuximab

Imaging study

Intervention Type OTHER

PET-CT

Interventions

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Imaging study

PET-CT

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically proven colorectal cancer
* Unresectable stage IV disease
* K-Ras wild type tumour
* Patients scheduled to undergo chemotherapy with irinotecan and cetuximab

Exclusion Criteria

* Prior abdominal/pelvic radiotherapy, surgery or chemotherapy within 3 months prior to inclusion in the study
* Poorly controlled diabetes
* Concomitant serious illness, such as uncontrolled angina pectoris, myocardial infarction, heart failure, uncontrolled hypertension, infection
* Symptomatic brain metastases
* Pregnancy or participants of reproductive potential who are sexually active and not willing/able to use medically appropriate contraception
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Van Cutsem, Prof.Dr

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

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ZNA Middelheim

Antwerp, , Belgium

Site Status

AZ Groeninge

Kortrijk, , Belgium

Site Status

UZLeuven

Leuven, , Belgium

Site Status

H Hart Roeselare Campus menen

Menen, , Belgium

Site Status

Stedelijk Ziekenhuis Roeselare

Roeselare, , Belgium

Site Status

Sint Augustinus Ziekenhuis

Wilrijk, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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s51276 - ML5241

Identifier Type: -

Identifier Source: org_study_id