An observational study in Lung Cancer, sponsored by Rabin Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2016-11-18.
Sponsored by Rabin Medical Center · Observational
The purpose of this study is to evaluate the use of Dynamic PET/CT as a tool to assess disease response to anti-cancer therapy in Lung Cancer patients.
Background:
Lung cancer is a devastating disease in which the response for first line therapy is only 30%. Evaluating response is performed normally by a CT or PET-CT scans after 2-3 cycles of therapy, thus, lack of response is been evaluated only after the patient has been treated following significant amount of therapy, which is inefficient in 70% of cases.
Therefore, there is an urgent need to develop tools that might predict response to therapy during the early course of therapy; Most valuable will be before or after the first cycle of therapy. For that reason, the investigators aim in this study to evaluate the use of Dynamic PET-CT as a tool to assess disease response to anti-cancer therapy in Lung Cancer patients.
Objectives:
Method:
200 advanced lung cancer patients will be enrolled over 3 years in a single institute, single arm study at Rabin Medical Center, Beilinson Hospital.
Patients will be evaluated by a Dynamic PET-CT protocol: before initiation of therapy, 7-14 days after the first therapy cycle, 3 months after initiation of therapy and 6 months after the first therapy cycle. In addition, non-invasive biomarkers that are routinely measured including protein markers (CEA- Carcinoembryonic Antigen, CYFRA21- Cytokeratin 19 Fragment, NSE- Neuron Specific Enolase) will be assessed in this trial.
Disease response will be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST criteria).
Additional PET-CT will not increase radiation dose significantly. The mean estimated radiation dose for a limited CT of the chest is about 14 mSv (i.e., 7mSv for limited diagnostic CT and FDG ([18F]-fluorodeoxyglucose), each). The dynamic stage will add radiation dose of about 0.3mSv. Of note, the significance of adding radiation dose is less of importance with regard to treatment of patients with aggressive cancer.
7,333 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.
This study's planned enrollment of 200 is close to the median of 190 across 1,547 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Rabin Medical Center is the lead sponsor of 393 studies on the registry; 30 are open to participants now.
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Advanced lung cancer patients (Stage 4)
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Exclusion Criteria:
People that were diagnosed with advanced lung cancer.
Compare baseline PET-CT with PET-CT after 7-14 days.
Time frame: 12 months
Evaluate disease-free survival (DFS) in lung cancer by using dynamic PET-CT.
Time frame: 12 months
Evaluate overall survival rate (OS) in lung cancer by using dynamic PET-CT.
Time frame: 12 months
Measuring response to treatment by PET-CT.
Time frame: 12 months
Plan to share: No — article will be released
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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