Predictive Value of FDG-PET-CT Scans for Patients With Lung Cancer Receiving Concurrent Chemo-Radiation (FDG-PET lung)
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|ClinicalTrials.gov Identifier: NCT00522639|
Recruitment Status : Terminated (Poor accrual)
First Posted : August 30, 2007
Last Update Posted : June 30, 2009
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer SCLC NSCLC||Other: 18F-deoxyglucose (FDG)||Phase 3|
This translational research part is aiming to give more insights in the way radiation injury and tumour response develops.
It involves three parts:
- Repetitive FDG-PET-CT scans in order to assess early tumour response monitoring.
- Blood sampling before, during and after radiotherapy in order to find predictors for normal tissue injury and for tumour response.
- Extra staining of tumour biopsies
The FDG-PET-CT scan with i.v. contrast gives information of the tumour metabolism and its morphology. Therefore, one extra FDG-PET-CT scans will be done during radiotherapy at day 8. Tumour response will be determined by FDG-PET-CT scans 3 months after radiotherapy.
- Before radiotherapy, 12 millilitres of blood (EDTA tubes) will be taken according to serum protocol (appendix 5).
- At day 7, day 14 during concurrent chemo-radiation, 7 days after the end of this treatment and 3 months and 9 months after the end of radiotherapy, 12 millilitres serum (EDTA tube) will be taken to investigate the evolution of the proteins [In the first place, plasma concentrations of osteopontin and soluble CA9 for hypoxia, CRP and IL-6 for inflammation, total and free VEGF for angiogenesis and total and cleaved cytokeratin 18 for necrosis/apoptosis will be determined] during and after treatment, for its kinetics may be important as predictive factors. Standard ELISA tests will be used to determine these levels.
- Before radiotherapy, at day 7 and at day 14 during radiation, 7 days after the end of this treatment and 3 months and 9 months after the end of radiotherapy, 24 millilitres of blood (EDTA tubes) will be taken to investigate the evolution of circulating cells and their progenitors during and after treatment.
The tumour biopsies may be stained with markers for proliferation (e.g. KI 67), apoptosis (e.g. M30), hypoxia (e.g. CA 9, Glut 1 and 3) and others (e.g. EGFR and EGFRvIII), in order to correlate these measurements with response.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Determination of the Predictive Value of FDG-PET-CT Scans, Blood Proteins and Blood Cells for the Prognosis for Patients With Lung Cancer Receiving Concurrent Chemo-Radiation|
|Study Start Date :||October 2008|
|Study Completion Date :||June 2009|
Other: 18F-deoxyglucose (FDG)
- Tumour response, measured with FDG-PET-CT scans 3 months post-radiation. as a function of delta FDG uptake the first week during radiotherapy [ Time Frame: 9 months post-radiation ]
- - Incidence of acute radiation-induced oesophagitis - Incidence of radiation-induced pulmonary toxicity 3 and 9 months post-radiation [ Time Frame: 9 months post-radiation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00522639
|Maastricht Radiation Oncology, MAASTRO|
|Maastricht, Limburg, Netherlands|
|Principal Investigator:||Dirk De Ruysscher, MD PhD||MAASTRO, Maastricht Radiation Oncology|