Multimodal Functional Imaging Combined With Metabolomics in Predicting the Efficacy of nCRT for Locally Advanced ESCC
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04759235|
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : February 18, 2021
Esophageal cancer (EC) is the seventh most frequently diagnosed cancers and the sixth leading causes of cancer death worldwide . It is one of the most common malignancy in China, with the third highest morbidity and mortality rate. More than 90% of patients with EC in China have esophageal squamous cell carcinoma (ESCC). Neoadjuvant chemoradiotherapy (nCRT) followed by surgery is currently widely used strategy for locally advanced surgical EC.
At present, conventional imaging methods have certain defects (focus only on the volume change) in the evaluation of the efficacy of nCRT. Whereas functional imaging can more comprehensively reflect the biological and microstructural characterization of tumors. The changes of these aspects of tumors can be observed earlier than volumetric changes of tumors.
The normal metabolism of the body is the basis for ensuring life activities. Due to the increased energy demand and proliferation of tumor tissue in patients with cancer, the metabolism of patients is different from that of normal person. Thus, the metabolic alterations seen in cancer cells have emerged as one of the hallmarks of cancer. Previous metabolomic studies have demonstrated various metabolic alterations in patients with ESCC. Many metabolites have been found to be promising diagnostic, staging or prognostic biomarkers for ESCC. However, there are few studies on metabolic markers on the chemoradiation sensitivity of esophageal cancer.
Therefore, the aim of the present study is to evaluate the value of functional imaging parameters and metabolic markers in assessing and predicting pathological response in patients who underwent nCRT for ESCC.
|Condition or disease||Intervention/treatment|
|Esophageal Squamous Cell Carcinoma||Diagnostic Test: Magnetic resonance imaging (MRI) Diagnostic Test: 18F-Fluorodeoxyglucose (FDG)-positron emission tomography/computed tomography (PET/CT) Diagnostic Test: Blood and urine metabolic biomarker|
|Study Type :||Observational|
|Estimated Enrollment :||118 participants|
|Official Title:||Multimodal Functional Imaging Combined With Metabolomics in Predicting the Efficacy of Neoadjuvant Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma|
|Actual Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
neoadjuvant chemoradiotherapy of local advanced ESCC
All the patients receive paclitaxel/cisplatin chemotherapy and concurrent radiotherapy. Each patient receives radiation of 41.4 Gy / 23 fractions complied by intensity modulated radiotherapy or volumetric modulated arc therapy. Patients without disease progression after nCRT will be scheduled for surgery and patients with disease progression (PD) will continue to receive chemoradiation or additional treatments. Surgery will be performed 6 to 8 weeks after completion of chemoradiotherapy.
Diagnostic Test: Magnetic resonance imaging (MRI)
Anatomical (T2W) and functional MRI (DWI) at a 3.0T Siemens or Philips scanner Three MRI scan series (before, during, after nCRT) Measurements: change in apparent diffusion coefficient (ADC)
Other Name: Diffusion-weighted magnetic resonance imaging (DW-MRI)
Diagnostic Test: 18F-Fluorodeoxyglucose (FDG)-positron emission tomography/computed tomography (PET/CT)
PET-CT scan at diagnosis and 4-6 weeks after nCRT before operation Measurements: change in TLG (Total Lesion Glycolysis), SUVmax (Standardized Uptake Value)，MTV（Metabolic tumor volume）
Diagnostic Test: Blood and urine metabolic biomarker
Blood and urine specimens are collected before radiotherapy, the third week of radiotherapy, and at the end of radiotherapy.
- Histopathologic response [ Time Frame: Based on resection specimen (surgery 6-8 weeks after finishing nCRT) ]Histopathologic response of the primary tumor to nCRT according to the tumor regression grade (TRG) scale as determined by expert pathologist. TRG 1(pCR): no residual viable tumor cells, pathologic complete response TRG 2: rare residual cancer cells TRG 3: predominant fibrosis with increased number of residual cancer cells TRG 4: residual cancer outgrowing fibrosis or no regressive change
- ∆ADC [ Time Frame: within 2 weeks before the start of nCRT，2 weeks after the start of nCRT and 4-6 weeks after the completion of nCRT ]change of apparent diffusion coefficient in DW-MRI and difference between pCR group and non-pCR group
- ∆TLG [ Time Frame: within 2 weeks before the start of nCRT，2 weeks after the start of nCRT and 4-6 weeks after the completion of nCRT ]change of total lesion glycolysis in PET/CT and difference between pCR group and non-pCR group
- change of metabolites [ Time Frame: within 2 weeks before the start of nCRT and 4-6 weeks after the completion of nCRT ]change of metabolites after chemoradiotherapy and differences between pCR group and non-pCR group
- Disease-free survival [ Time Frame: Up to 5-year follow-up ]time to locoregional or distal recurrence
- Overall survival [ Time Frame: Up to 5-year follow-up ]time to die or follow-up deadline
Biospecimen Retention: Samples Without DNA
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): NCT04759235
|Contact: Xiumei Ma, Doctorfirstname.lastname@example.org|
|Shanghai, Shanghai, China, 200127|
|Contact: Xiumei Ma, Doctor 021-68383624 email@example.com|
|Principal Investigator: Xiumei Ma, Doctor|