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

Imaging for Early Response Prediction to EGF-receptor Blocking Monoclonal Antibodies in Combination Therapy for Colorectal Cancer

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00828620

Enrollment

Registered

2009-01-26

Start date

2009-01-31

Completion date

2012-06-30

Last updated

2012-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Colorectal Cancer

Brief summary

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.

Interventions

OTHERImaging study

PET-CT

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
PET response on day 7	day 7

Secondary

Measure	Time frame
To determine whether the PET criteria for response on day 7 correlates with the CT criteria of minimum 10% decrease in tumour size (RECIST) at week 6	week 6
To define the optimal cutoff value of SUVmax and their predictive value	at day 7 and week 6
To explore the test/retest reliability of PET/CT in this setting	2 weeks
To assess the value of PET/CT at day 7 in predicting overall survival	up to 1 year
To asses the correlations between biomarkers and PET changes after Cetuximab	up to 6 months

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026