Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of recruitment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imaging study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- PET-CT
- description
- Patients with Unresectable stage IV colorectal cancer; eligible for 3rd line Irinotecan and Cetuximab
- interventionNames
- Other: Imaging study
Primary outcomes (1)
- measure
- PET response on day 7
- timeFrame
- day 7
Secondary outcomes (5)
- measure
- 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
- timeFrame
- week 6
- measure
- To define the optimal cutoff value of SUVmax and their predictive value
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available