Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prediction of Neoadjuvant Chemotherapy Efficacy in Locally Advanced Gastric Cancer

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: NCT05140746
Recruitment Status : Recruiting
First Posted : December 1, 2021
Last Update Posted : December 1, 2021
Sponsor:
Information provided by (Responsible Party):
Ruijin Hospital

Brief Summary:
This study intends to explore the value of 68Ga-FAPI-04 and 18F-FDG PET/CT in the evaluation of treatment response to neoadjuvant chemotherapy(NAC) for patients with locally advanced gastric cancer(LAGC).

Condition or disease Intervention/treatment Phase
Gastric Cancer Diagnostic Test: 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT Not Applicable

Detailed Description:
Before the start of NAC, baseline 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT scans will be scheduled in all enrolled patients. Next, the patients with resectable LAGC will receive NAC treatment, surgery will follow 3~6 weeks after finishing NAC. Abdomen 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT will be scheduled after one cycle of NAC treatment or before surgery. Imaging response measurements will be compared with the histopathological tumor regression grade (TRG) of the resection specimen as gold standard.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective Study on Predicting the Efficacy of Neoadjuvant Chemotherapy in Locally Advanced Gastric Cancer.
Actual Study Start Date : September 10, 2020
Estimated Primary Completion Date : September 10, 2022
Estimated Study Completion Date : September 10, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: PET/CT for prediction of NAC efficacy
68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT will be scanned before, during or after NAC.
Diagnostic Test: 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT
Baseline 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT scans before NAC followed by abdomen 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT scans after one cycle of NAC treatment or before surgery.




Primary Outcome Measures :
  1. Prediction for NAC efficacy [ Time Frame: Two weeks after surgery ]
    Predictive value of 68Ga-FAPI PET/CT and 18F-FDG PET/CT for LAGC in NAC response assessment.

  2. Standardized uptake value(SUV) [ Time Frame: Two weeks after surgery ]
    SUV of 68Ga-FAPI and 18F-FDG uptake on PET/CT images for primary gastric cancer.

  3. Target-to-background ratio(TBR) [ Time Frame: Two weeks after surgery ]
    68Ga-FAPI and 18F-FDG uptake ratio of primary gastric cancer to mediastinum blood pool on PET/CT images.


Secondary Outcome Measures :
  1. Diagnostic efficacy for metastatic lymph nodes [ Time Frame: Two weeks after surgery ]
    The sensitivity, specificity, NPV, PPV and accuracy of 68Ga-FAPI PET/CT for metastatic lymph nodes in comparison with those of 18F-FDG PET/CT.

  2. Disease free survival [ Time Frame: 5 years ]
    Disease free survival

  3. Overall survival [ Time Frame: 5 years ]
    Overall survival



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. Age between 18-75 years.
  2. Histologically confirmed gastric adenocarcinoma through gastroscopy.
  3. Resectable gastric cancer.
  4. ECOG performance status 0-1.
  5. White blood count >4x109/L, Absolute neutrophil count (ANC) >2x109/L, Hemoglobin (Hb)>90g/L, Platelets >100x109/L.
  6. Ejection Fraction>50%.
  7. Serum bilirubin <1.5x ULN; ALT and AST <1.5x ULN.
  8. Serum creatinine ≤1.5x ULN, or GFR> 60ml/min.
  9. Agreement to participate in this study with informed consent form.
  10. Willingness and ability to comply with the protocol for the duration of the study.
  11. No children bearing petential in the next six months before enrollment.

Exclusion criteria

  1. With second primary malignant diseases in past five years, exceptions include basal cell and squamous cell carcinoma of the skin that have been cured.
  2. Known hypersensitivity reaction to chemotherapy drugs or with contraindications.
  3. With severe disease or other unsuitable conditions determined by investigators. Inadequate organ function.
  4. With uncontrollable diabetic or fasting blood glucose level ≥11 mmol/L on the test-day.
  5. With severe mental symptoms, unconscious or unable to complete the examination.
  6. Pregnancy or possibly pregnant woman, breastfeeding woman.
  7. Lack of compliance.

Information from the National Library of Medicine

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): NCT05140746


Contacts
Layout table for location contacts
Contact: Ying Miao 0086-13671921521 myada821@hotmail.com

Locations
Layout table for location information
China, Shanghai
Shanghai Ruijin Hospital Recruiting
Shanghai, Shanghai, China, 200025
Contact: Runhua Feng    0086-13611920056    frh10960@rjh.com.cn   
Principal Investigator: Zhenggang Zhu         
Sponsors and Collaborators
Ruijin Hospital
Investigators
Layout table for investigator information
Principal Investigator: Zhenggang Zhu Ruijin Hospital
Layout table for additonal information
Responsible Party: Ruijin Hospital
ClinicalTrials.gov Identifier: NCT05140746    
Other Study ID Numbers: PET-NAC-GC
First Posted: December 1, 2021    Key Record Dates
Last Update Posted: December 1, 2021
Last Verified: November 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action