Clinical trial · Interventional
Rectal Study: Value of Repeated FDG-PET-CT Scans in Rectal Cancer
Rectal Cancer: Determination of the Predictive Value by Use of FDG-PET-CT Scans and Blood Proteins for the Prognosis of Patients With Rectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To investigate the evolution of the 18F-deoxyglucose (FDG) uptake and the tumour characteristics determined in the plasma of patients with rectal cancer during and after radiotherapy or combined radiotherapy and chemotherapy. The changes of the FDG uptake of the primary tumour and the evolution of key tumour characteristics during radiotherapy alone or in combination with chemotherapy will be predictive for the pathological tumour response. Study hypothesis The changes of the FDG uptake of the primary tumour and the evolution of key tumour characteristics during radiotherapy alone or in combination with chemotherapy will be predictive for the pathological tumour response.
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 |
|---|---|---|---|
| Rectum Cancer | Rectal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FDG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- FDG PET CT
- description
- To investigate the evolution of the 18F-deoxyglucose (FDG) uptake and the tumour characteristics determined in the plasma of patients with rectal cancer during and after radiotherapy or combined radiotherapy and chemotherapy.
- interventionNames
- Drug: FDG
Primary outcomes (1)
- measure
- The metabolic tumour response by PET scan will be determined according to the EORTC criteria (appendix 1)61. The pathological tumour response will be determined according to Dworak and Wheeler.62,63
- timeFrame
- 5 years
Secondary outcomes (1)
- measure
- Clinical examination(weight, performance status including the CTCv3.0 scale for acute and late reactions)
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological proven rectal cancer * UICC stage I-IV * WHO performance status 0-2 * Less than 10 % weight loss in the last 6 months * In case of previous chemotherapy, radiotherapy can start after a minimum of 21 days after the last chemotherapy course * No recent (\< 3 months) severe cardiac disease (arrhythmia, congestive heart failure,infarction) * Life expectancy more than 6 months * Measurable cancer * Willing and able to comply with the study prescriptions * 18 years or older * Not pregnant and willing to take adequate contraceptive measures during the study * Have given written informed consent before patient registration * No previous radiotherapy to the pelvis Exclusion Criteria: * Not adenocarcinoma histology * History of prior pelvis radiotherapy * Recent (\< 3 months) myocardial infarction * Uncontrolled infectious disease * Less than 18 years old * Pregnant or not willing to take adequate contraceptive measures during the study
References
Publications (0)
Data not yet available