Multimodal Functional Imaging Combined With Metabolomics in Predicting the Efficacy of nCRT for Locally Advanced ESCC

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

Multimodal Functional Imaging Combined With Metabolomics in Predicting the Efficacy of Neoadjuvant Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04759235
• Other study ID #: KY2020-032
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2021
• Source: RenJi Hospital
• Contact: Xiumei Ma, Doctor
• Phone: 13611983139
• Email: sallyma[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Pathologically confirmed esophageal squamous cell carcinoma;

• AJCC 7th edition staging T3-T4a or N+;

• No radiotherapy or chemotherapy in the past;

• 18-75 years old;

• Hematology, biochemical and organ function indicators meet the following requirements:

1) White blood cells = 3.0 x109/ L; 2)neutrophil cells = 1.5 x109/ L; 3) Platelet count =85 x109/L; 4) Hemoglobin =90 g/L; 5) Total bilirubin =1.5 times normal value; 6) ALT= 1.5 x normal value; AST =1.5 times the normal value; 7) Serum creatinine =1.5 times the normal value, and creatinine clearance rate (Ccr) =60ml/min (Cockcroft-Gault);

• ECOG score 0-1 points;

• Able to eat a semi-liquid diet;

• sign an informed consent.

Exclusion Criteria:

• Have received radiotherapy or systemic chemotherapy;

• During pregnancy or lactation;

• Uncontrollable serious medical diseases;

• Unable to sign informed consent;

• With distant metastasis;

• Suffering from the second type of malignant tumor (except skin squamous cell carcinoma and carcinoma in situ of other organs) within the past 5 years;

• Those who cannot receive MRI examination;

• Chemotherapy drugs or contrast agents Allergic.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

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)
• 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)
• Blood and urine metabolic biomarker
Blood and urine specimens are collected before radiotherapy, the third week of radiotherapy, and at the end of radiotherapy.

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histopathologic response	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	Based on resection specimen (surgery 6-8 weeks after finishing nCRT)
Primary	?ADC	change of apparent diffusion coefficient in DW-MRI and difference between pCR group and non-pCR group	within 2 weeks before the start of nCRT,2 weeks after the start of nCRT and 4-6 weeks after the completion of nCRT
Primary	?TLG	change of total lesion glycolysis in PET/CT and difference between pCR group and non-pCR group	within 2 weeks before the start of nCRT,2 weeks after the start of nCRT and 4-6 weeks after the completion of nCRT
Primary	change of metabolites	change of metabolites after chemoradiotherapy and differences between pCR group and non-pCR group	within 2 weeks before the start of nCRT and 4-6 weeks after the completion of nCRT
Secondary	Disease-free survival	time to locoregional or distal recurrence	Up to 5-year follow-up
Secondary	Overall survival	time to die or follow-up deadline	Up to 5-year follow-up